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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrosurgical, cutting & coagulation & accessories
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeGEI
Regulation Number 878.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
ADEOR MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AESCULAP INC.
  SUBSTANTIALLY EQUIVALENT 2
AESTHETIC MANAGEMENT PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
AESTHETICS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AGNES MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
ALIC IOTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
APYX MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
APYX MEDICAL CORPORATION (FORMERLY BOVIE MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
APYX MEDICAL CORPORATION(FORMERLY BOVIE MEDICAL CORPORATION)
  SUBSTANTIALLY EQUIVALENT 1
ARTHROCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
AUCKLAND MEDICAL POLYMER(TIANJIN) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AUGUSTINE TEMPERATURE MANAGEMENT LLC
  SUBSTANTIALLY EQUIVALENT 1
AXON SPINE MEDICAL SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
BAISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING TAKTVOLL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BIPAD SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOLDER SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
BOLDER SURGICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
BOMTECH ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOWA-ELECTRONICS GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BRERA MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
BTL
  SUBSTANTIALLY EQUIVALENT 2
BTL INDUSTRIES INC.
  SUBSTANTIALLY EQUIVALENT 5
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C2DX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBRIDGE INTERVENTIONAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CARTESSA AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
CHUNGWOO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CLASSYS INC.
  SUBSTANTIALLY EQUIVALENT 1
CNC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COMPAL ELECTRONICS, INC
  SUBSTANTIALLY EQUIVALENT 1
COMPEX, SPOL, S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 5
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 3
CREO MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
CROSS VASCULAR INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTERA INC.
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE LLC
  SUBSTANTIALLY EQUIVALENT 1
CYNOSURE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DANNIK
  SUBSTANTIALLY EQUIVALENT 2
DANNIK LLC
  SUBSTANTIALLY EQUIVALENT 2
DELTRONIX EQUIPAMENTOS LTDA
  SUBSTANTIALLY EQUIVALENT 1
DEX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN QUANDING MEDICAL SUPPLIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
E SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ELLUSA, LLC
  SUBSTANTIALLY EQUIVALENT 4
ENCISION INC.
  SUBSTANTIALLY EQUIVALENT 1
ENCISION INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ENERGIST LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 3
ETHICON ENDO-SURGERY
  SUBSTANTIALLY EQUIVALENT 1
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 4
ETHICON ENDO-SURGERY, LLC (A JOHNSON AND JOHNSON COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
EUNSUNG GLOBAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXCELSIOR RESOURCES LLC
  SUBSTANTIALLY EQUIVALENT 1
F CARE SYSTEMS USA LLC
  SUBSTANTIALLY EQUIVALENT 1
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 1
FULWELL LLC
  SUBSTANTIALLY EQUIVALENT 1
GMV S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
GUANGZHOU AIMIRA INNOVATION TECHNOLOGY CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GUENTER BISSINGER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 2
HG INNOVATIONS LTD
  SUBSTANTIALLY EQUIVALENT 3
HIRONIC CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HIRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
HOOGLAND SPINE PRODUCTS, GMBH
  SUBSTANTIALLY EQUIVALENT 1
HS HOSPITAL SERVICE SPA
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO,.LTD.
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
INBELLA MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
INDIBA S.A.U
  SUBSTANTIALLY EQUIVALENT 1
INMODE LTD.
  SUBSTANTIALLY EQUIVALENT 7
INMODE MD LTD.
  SUBSTANTIALLY EQUIVALENT 1
INNOBLATIVE DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA MICROFRANCE
  SUBSTANTIALLY EQUIVALENT 1
INTELIS INSTRUMENTS LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL
  SUBSTANTIALLY EQUIVALENT 4
INVUITY INC.
  SUBSTANTIALLY EQUIVALENT 1
ITALIAN ENGINEERING SRL
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
JEISYS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU BONSS MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HAIZE MEDICAL SCIENTIFIC DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HOPE BIOMEDICAL SCIENCE & TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU HOPE BIOMEDICAL SCIENCE&TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RONG FU KANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KATALYST SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
KIRWAN SURGICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
LED SPA
  SUBSTANTIALLY EQUIVALENT 1
LINA MEDICAL APS
  SUBSTANTIALLY EQUIVALENT 1
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 10
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTIRES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDRANGE
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
  SUBSTANTIALLY EQUIVALENT 4
NEAUVIA NORTH AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 3
NEURENT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NEW DEANTRONICS TAIWAN LTD
  SUBSTANTIALLY EQUIVALENT 2
NEW DEANTRONICS TAIWAN, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NINGBO SHUN YE MEDICAL COMPANY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NISSHA MEDICAL TECHNOLOGIES LTD
  SUBSTANTIALLY EQUIVALENT 1
NOVOXEL LTD.
  SUBSTANTIALLY EQUIVALENT 2
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER & IBE GMBH
  SUBSTANTIALLY EQUIVALENT 4
PAVMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN LTD
  SUBSTANTIALLY EQUIVALENT 1
POLLOGEN LTD.
  SUBSTANTIALLY EQUIVALENT 3
PULSE BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 7
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 2
RELIGN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
RF MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 3
RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS
  SUBSTANTIALLY EQUIVALENT 1
ROHRER AESTHETICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAFER SURGERIES MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SCITON, INC.
  SUBSTANTIALLY EQUIVALENT 1
SEJONG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENB CO LTD
  SUBSTANTIALLY EQUIVALENT 5
SHENB CO LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENB CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHENZHEN MECUN MEDICAL SUPPLY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHENSHI SINCOHEREN S&T DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHINING WORLD HEALTH CARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SINGLE PASS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SKINGRAB CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SONIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 3
STARMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
STERIS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SURGICAL PRINCIPALS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGNOVA HEALTHCARE TECHNOLOGIES (ZHEJIANG) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SURNIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SUTTER MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
TENTECH INC.
  SUBSTANTIALLY EQUIVALENT 1
TITAN MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIWORKS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES ENDOSCOPY GROUP, INC
  SUBSTANTIALLY EQUIVALENT 1
VENCLOSE, INC.
  SUBSTANTIALLY EQUIVALENT 2
VENUS CONCEPT USA INC.
  SUBSTANTIALLY EQUIVALENT 2
VHMED (NANTONG) CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIOL CO. LTD
  SUBSTANTIALLY EQUIVALENT 1
VIOL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VIVEVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
VIVEVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WON TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 6490 6490
2021 6351 6351
2022 6103 6103
2023 7177 7177
2024 7899 7900
2025 618 618

Device Problems MDRs with this Device Problem Events in those MDRs
Break 3963 3963
Adverse Event Without Identified Device or Use Problem 3644 3644
Energy Output Problem 2748 2748
Detachment of Device or Device Component 2299 2299
Electrical /Electronic Property Problem 1855 1855
Difficult to Open or Close 1815 1815
Peeled/Delaminated 1399 1399
Output Problem 1192 1192
Self-Activation or Keying 772 772
Insufficient Information 746 746
Material Twisted/Bent 737 738
Material Separation 732 732
Device Displays Incorrect Message 706 706
Failure to Deliver Energy 695 695
Mechanical Problem 689 689
Retraction Problem 658 658
Device Alarm System 568 568
Protective Measures Problem 524 524
Delivered as Unsterile Product 522 522
Infusion or Flow Problem 519 519
Application Program Problem: Parameter Calculation Error 515 515
Activation Problem 503 503
Overheating of Device 489 489
Failure to Cut 481 481
Appropriate Term/Code Not Available 470 470
Connection Problem 467 467
Sparking 463 463
Communication or Transmission Problem 441 441
Fire 427 427
Material Fragmentation 421 421
Melted 398 398
Use of Device Problem 373 373
No Apparent Adverse Event 363 363
Intermittent Energy Output 358 358
Fracture 354 354
Electrical Shorting 349 349
Material Integrity Problem 349 349
Device Remains Activated 315 315
Arcing 276 276
Mechanical Jam 259 259
Defective Device 257 257
Smoking 249 249
Unintended Power Up 240 240
Continuous Firing 220 220
Inaccurate Delivery 186 186
Fitting Problem 181 181
Material Deformation 171 171
Separation Problem 163 163
Arcing of Electrodes 162 162
Blocked Connection 160 160

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22005 22006
No Consequences Or Impact To Patient 3369 3369
Insufficient Information 2085 2085
Burn(s) 1678 1678
Hemorrhage/Bleeding 1474 1474
No Patient Involvement 703 703
No Known Impact Or Consequence To Patient 701 701
Partial thickness (Second Degree) Burn 496 496
Superficial (First Degree) Burn 488 488
Foreign Body In Patient 396 396
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 339 339
No Information 259 259
Unspecified Tissue Injury 258 258
Full thickness (Third Degree) Burn 255 255
Pain 205 205
Erythema 187 187
Blister 173 173
No Code Available 150 150
Hematoma 141 141
Injury 129 129
Scar Tissue 127 127
Unspecified Infection 102 102
Blood Loss 101 101
Electric Shock 100 100
Skin Discoloration 83 83
Bowel Perforation 80 80
Thrombosis/Thrombus 77 77
Perforation 73 73
Laceration(s) 71 71
Necrosis 67 67
Swelling/ Edema 66 66
Burn, Thermal 65 65
Skin Inflammation/ Irritation 56 56
Fistula 52 52
Not Applicable 51 51
Unintended Radiation Exposure 49 49
Abscess 49 49
Fever 46 46
Inflammation 46 46
Post Operative Wound Infection 45 45
Pneumothorax 44 44
Bowel Burn 42 42
Device Embedded In Tissue or Plaque 39 39
Nerve Damage 38 38
Tissue Damage 38 38
Abdominal Pain 36 36
Cardiac Arrest 33 33
Bruise/Contusion 33 33
Pleural Effusion 33 33
Stenosis 33 33

Recalls
Manufacturer Recall Class Date Posted
1 Aerin Medical, Inc. II Jan-06-2025
2 Aesculap Implant Systems LLC II May-05-2023
3 Aomori Olympus Co., Ltd. II Feb-05-2021
4 Bard Peripheral Vascular Inc II Nov-13-2024
5 Beaver Visitec International, Inc. II Jun-23-2022
6 Bolder Surgical, LLC II Mar-08-2022
7 Boston Scientific Corporation II Dec-22-2020
8 Bovie Medical Corporation II Feb-26-2021
9 Bovie Medical Corporation II May-20-2020
10 Carefusion 2200 Inc II Dec-03-2022
11 ConMed Corporation II Dec-09-2022
12 CooperSurgical, Inc. II Jun-10-2021
13 Covidien II Jan-03-2024
14 Covidien II Apr-12-2021
15 Covidien Llc II Jan-13-2022
16 Covidien Llc II Feb-25-2020
17 Intuitive Surgical, Inc. II May-31-2022
18 Kirwan Surgical Products, LLC I Dec-16-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Sep-06-2024
20 Maquet Cardiovascular, LLC I Jan-03-2025
21 Maquet Cardiovascular, LLC I Oct-25-2024
22 Maquet Cardiovascular, LLC II Jul-11-2024
23 Maquet Cardiovascular, LLC II Jun-24-2024
24 Maquet Cardiovascular, LLC II Jan-12-2024
25 Maquet Cardiovascular, LLC II Nov-02-2023
26 Maquet Cardiovascular, LLC II Apr-04-2023
27 Maquet Cardiovascular, LLC II Jan-19-2023
28 Mckesson Medical-Surgical Inc. Corporate Office II Aug-26-2022
29 Megadyne Medical Products, Inc. I Jul-03-2024
30 Megadyne Medical Products, Inc. I Jun-06-2024
31 Megadyne Medical Products, Inc. I Dec-26-2023
32 Megadyne Medical Products, Inc. II Jul-28-2023
33 Megadyne Medical Products, Inc. I Jun-30-2023
34 Microline Surgical, Inc. II Dec-10-2024
35 Nico Corp. II Jun-09-2021
36 Olympus Corporation of the Americas II Oct-30-2024
37 Olympus Corporation of the Americas II Aug-08-2024
38 Olympus Corporation of the Americas II Jul-23-2024
39 Olympus Corporation of the Americas II Apr-30-2024
40 Olympus Corporation of the Americas II Feb-20-2024
41 Olympus Corporation of the Americas II Sep-26-2022
42 Olympus Corporation of the Americas II Aug-27-2021
43 Solta Medical Inc II Apr-07-2023
44 Solta Medical Inc II Apr-07-2020
45 Steris Corporation II Nov-16-2022
46 Stryker Corporation II Feb-11-2025
47 Stryker Corporation II Jan-06-2025
48 Stryker Corporation II Nov-13-2024
49 Stryker Corporation II Nov-07-2023
50 Stryker Corporation II Mar-17-2020
51 Stryker Instruments Div. of Stryker Corporation II Apr-28-2020
52 Stryker Instruments Div. of Stryker Corporation II Jan-28-2020
53 Sutter Medizintechnik GmbH II Jul-31-2020
54 Zimmer, Inc. II Nov-01-2024
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