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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
ACOTEC SCIENTIFIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AERIN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
AESTHETIC MANAGEMENT PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
AESTHETICS BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AGNES MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
ALIC IOTECH, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALMA LASERS, INC.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
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 5
ASTERASYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ATRAVERSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 1
AXON SPINE MEDICAL SYSTEM
  SUBSTANTIALLY EQUIVALENT 1
BAISHENG MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
BAYLIS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING TAKTVOLL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
BOLDER SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 4
BOMTECH ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON AESTHETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BRERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BTL
  SUBSTANTIALLY EQUIVALENT 1
BTL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
C2DX, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANDELA CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CELLAH MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHUNGWOO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CINTRON MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CLASSYS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CNC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CNS MEDICAL CO., LTD.
  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 6
CREO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CROSS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTERA, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYNOSURE, LLC
  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 2
ENDYMED MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENERGIST LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ENTIRE MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ERBE ELEKTROMEDIZIN GMBH
  SUBSTANTIALLY EQUIVALENT 7
ETHICON ENDO-SURGERY, LLC
  SUBSTANTIALLY EQUIVALENT 3
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 2
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
H.S HOSPITAL SERVICE S.P.A
  SUBSTANTIALLY EQUIVALENT 1
HG INNOVATIONS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
HIRONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
HOOGLAND SPINE PRODUCTS, GMBH
  SUBSTANTIALLY EQUIVALENT 1
ILOODA CO,., LTD.
  SUBSTANTIALLY EQUIVALENT 4
INBELLA MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
INBELLA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
INDIBA S. A. U.
  SUBSTANTIALLY EQUIVALENT 1
INMODE , LTD.
  SUBSTANTIALLY EQUIVALENT 6
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
ITALIAN ENGINEERING S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
JEISYS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 2
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 8
LUTRONIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 3
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-TECH (NANJING) CO., LTD .
  SUBSTANTIALLY EQUIVALENT 1
MICROLINE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MODERN MEDICAL EQUIPMENT MANUFACTURING, LTD.
  SUBSTANTIALLY EQUIVALENT 2
NEAUVIA NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEURENT MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
NEURENT MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS WINTER &IBE GMBH
  SUBSTANTIALLY EQUIVALENT 5
POLLOGEN, LTD.
  SUBSTANTIALLY EQUIVALENT 5
PULSE BIOSCIENCES, INC.
  SUBSTANTIALLY EQUIVALENT 7
REBOUND THERAPEUTICS
  SUBSTANTIALLY EQUIVALENT 1
RELIGN CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
RELIGN CORPORATION, SUBSIDIARY OF ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
RF MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 7
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 4
STERIS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 3
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 1
TENTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
TITAN MANUFACTURING, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRIWORKS GROUP SRL
  SUBSTANTIALLY EQUIVALENT 1
VENCLOSE, INC.
  SUBSTANTIALLY EQUIVALENT 3
VENUS CONCEPT, INC.
  SUBSTANTIALLY EQUIVALENT 1
VHMED (NANTONG) CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIGEON TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VIOL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
VIVEVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIVEVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
WE MEDICAL TECHNOLOGY (WUXI) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
WONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG CURAWAY MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 6354 6367
2022 6103 6145
2023 7176 7184
2024 7897 7900
2025 7694 7694

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3688 3697
Break 3673 3681
Detachment of Device or Device Component 2751 2762
Energy Output Problem 2726 2728
Electrical /Electronic Property Problem 2080 2081
Difficult to Open or Close 1818 1818
Peeled/Delaminated 1665 1665
Output Problem 1184 1188
Communication or Transmission Problem 909 909
Self-Activation or Keying 810 811
Material Twisted/Bent 797 797
Device Displays Incorrect Message 709 710
Insufficient Information 708 708
Failure to Deliver Energy 697 697
Mechanical Problem 672 675
Retraction Problem 619 619
Device Alarm System 588 591
Infusion or Flow Problem 583 584
Material Separation 574 574
Overheating of Device 568 568
Intermittent Energy Output 553 556
Failure to Cut 535 535
Appropriate Term/Code Not Available 531 531
Application Program Problem: Parameter Calculation Error 520 520
Connection Problem 497 499
Fracture 466 466
Sparking 463 466
Material Fragmentation 461 461
Activation Problem 436 436
Use of Device Problem 434 434
Melted 422 422
Fire 398 404
Delivered as Unsterile Product 395 395
Device Remains Activated 360 360
No Apparent Adverse Event 359 359
Electrical Shorting 351 351
Protective Measures Problem 349 349
Material Integrity Problem 315 315
Arcing 285 287
Smoking 279 279
Unintended Power Up 262 262
Defective Device 241 245
Degraded 227 227
Mechanical Jam 223 224
Continuous Firing 210 210
Patient Device Interaction Problem 199 199
Fitting Problem 196 196
Activation Failure 189 189
Material Deformation 178 178
Excessive Heating 173 173

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 26615 26653
Insufficient Information 2424 2438
Hemorrhage/Bleeding 1734 1734
Burn(s) 1728 1730
Superficial (First Degree) Burn 558 559
Partial thickness (Second Degree) Burn 481 482
Foreign Body In Patient 433 435
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 370 374
Unspecified Tissue Injury 285 285
Full thickness (Third Degree) Burn 270 270
No Consequences Or Impact To Patient 242 242
Pain 225 227
Blister 209 209
Erythema 185 185
Scar Tissue 151 151
Hematoma 148 148
Unspecified Infection 117 117
Electric Shock 108 108
Thrombosis/Thrombus 99 99
Laceration(s) 90 90
Swelling/ Edema 89 89
Perforation 81 81
Necrosis 71 71
Bowel Perforation 70 70
Unintended Radiation Exposure 69 69
Skin Discoloration 65 65
Skin Inflammation/ Irritation 64 64
Nerve Damage 55 55
Tissue Breakdown 49 49
Bowel Burn 48 48
Post Operative Wound Infection 47 47
Fistula 47 47
Abscess 47 47
Fever 45 45
Pneumothorax 44 44
Internal Organ Perforation 41 41
Epistaxis 41 41
Inflammation 39 39
Pleural Effusion 37 37
Abdominal Pain 37 37
Bruise/Contusion 36 36
Deformity/ Disfigurement 36 36
No Patient Involvement 33 33
Numbness 31 31
Stenosis 30 30
Localized Skin Lesion 29 29
Tachycardia 29 29
Shock 28 28
Skin Tears 28 28
Cardiac Arrest 27 27

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