Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device laparoscope, general & plastic surgery
Regulation Description Endoscope 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 CodeGCJ
Regulation Number 876.1500
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVAMEDIX, GMBH
  SUBSTANTIALLY EQUIVALENT 2
ADVANCED MEDICAL DESIGN CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED SURGICAL CONCEPTS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED SURGICAL CONCEPTS LTD
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARK SURGICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHEX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
ASCLEPION LASER TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
BARCO NV
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORTATION
  SUBSTANTIALLY EQUIVALENT 1
BEIJING BIOSIS HEALING BIOLOGICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER LABORATORIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU ANKANG MEDICAL INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLEARCAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DANNIK
  SUBSTANTIALLY EQUIVALENT 1
DANNIK, LLC
  SUBSTANTIALLY EQUIVALENT 1
EIZO CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ENLIGHTENVUE, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM CORPORATON
  SUBSTANTIALLY EQUIVALENT 2
GUANGDONG OPTOMEDIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 5
GUANGZHOU TK MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU KANGJI MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HUMAN XTENSIONS LTD.
  SUBSTANTIALLY EQUIVALENT 5
HUNAN ENDOSO LIFE TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INCORE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL OPERATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTUITIVE SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
JIANGSU CHANNEL MEDICAL DEVICE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ ENDOSCOPY AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC
  SUBSTANTIALLY EQUIVALENT 1
LAGIS ENTERPRISE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LAZURITE HOLDINGS LLC
  SUBSTANTIALLY EQUIVALENT 1
LG ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 3
LIVSMED INC.
  SUBSTANTIALLY EQUIVALENT 1
LSI SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
M/S. MERIL ENDO SURGERY PRIVATE LIMITED.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOVASCULAR, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDEON BIODESIGN, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICONCEPTS TECHNOLOGY (SHENZHEN) COMPANY LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICROMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NDS SURGICAL IMAGING, LLC.
  SUBSTANTIALLY EQUIVALENT 1
NEW VIEW SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OMEC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OUI MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PLASMATICA LTD
  SUBSTANTIALLY EQUIVALENT 1
PRISTINE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
REGER MEDIZINTECHNIK, GMBH
  SUBSTANTIALLY EQUIVALENT 1
SANTA BARBARA IMAGING SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SCHOELLY FIBEROPTIC GMBH
  SUBSTANTIALLY EQUIVALENT 2
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SIDAM S.R.L
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH AND NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONY ELECTRONICS INC.
  SUBSTANTIALLY EQUIVALENT 1
STANDARD BARIATRICS
  SUBSTANTIALLY EQUIVALENT 1
STRYKER
  SUBSTANTIALLY EQUIVALENT 12
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 6
SURGICAL INNOVATIONS LIMITED
  SUBSTANTIALLY EQUIVALENT 1
T.A.G. MEDICAL PRODUCTS CORPORATION, LTD
  SUBSTANTIALLY EQUIVALENT 2
TAIWAN SURGICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERMASOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
TROCARE, LLC
  SUBSTANTIALLY EQUIVALENT 1
UNIMAX MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
US MEDICAL INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VEOL MEDICAL TECHNOLOGIES PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
WICKIMED (HUIZHOU) MEDICAL EQUIPMENT MANUFACTURING CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WUXI SHUKANG MEDICAL APPLIANCE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
XENOCOR, INC
  SUBSTANTIALLY EQUIVALENT 2
XIMEDICA
  SUBSTANTIALLY EQUIVALENT 2
XPAN INC.
  SUBSTANTIALLY EQUIVALENT 1
YUWONMEDITECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHUHAI DIPU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2620 2620
2021 3431 3431
2022 3945 3945
2023 6005 6005
2024 6048 6048
2025 2234 2234

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 4215 4215
Break 3067 3067
Detachment of Device or Device Component 2938 2938
Poor Quality Image 1678 1678
Material Split, Cut or Torn 1540 1540
Inflation Problem 1271 1271
Peeled/Delaminated 1265 1265
Communication or Transmission Problem 1263 1263
Leak/Splash 949 949
Material Fragmentation 791 791
Crack 592 592
Adverse Event Without Identified Device or Use Problem 536 536
Image Orientation Incorrect 495 495
Display or Visual Feedback Problem 468 468
Mechanical Problem 368 368
Packaging Problem 349 349
Erratic or Intermittent Display 315 315
Decrease in Pressure 300 300
Fluid/Blood Leak 284 284
Output Problem 283 283
Material Integrity Problem 279 279
Gas/Air Leak 269 269
Loss of or Failure to Bond 268 268
Insufficient Information 255 255
Optical Problem 237 237
Failure to Fire 230 230
Image Display Error/Artifact 195 195
Difficult to Insert 180 180
Material Separation 172 172
Noise, Audible 168 168
Unintended System Motion 148 148
Positioning Failure 145 145
Corroded 144 144
Device Contaminated During Manufacture or Shipping 139 139
Material Rupture 139 139
Failure to Power Up 134 134
Overheating of Device 124 124
Connection Problem 124 124
Premature Separation 123 123
Fracture 122 122
Electrical /Electronic Property Problem 121 121
Product Quality Problem 106 106
Temperature Problem 104 104
Mechanics Altered 99 99
Fogging 95 95
Difficult to Remove 94 94
Device Slipped 91 91
Smoking 90 90
Material Deformation 86 86
Delivered as Unsterile Product 85 85

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19936 19936
No Consequences Or Impact To Patient 1645 1645
Insufficient Information 1582 1582
Foreign Body In Patient 412 412
No Known Impact Or Consequence To Patient 345 345
No Patient Involvement 280 280
Unspecified Tissue Injury 188 188
Hemorrhage/Bleeding 161 161
No Information 91 91
No Code Available 74 74
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 51 51
Laceration(s) 45 45
Tissue Breakdown 45 45
Failure to Anastomose 41 41
Burn(s) 40 40
Pain 39 39
Peritoneal Laceration(s) 38 38
Device Embedded In Tissue or Plaque 37 37
Unintended Radiation Exposure 37 37
Unspecified Infection 36 36
Bowel Perforation 30 30
Hernia 28 28
Superficial (First Degree) Burn 26 26
Injury 26 26
Seroma 23 23
Abscess 21 21
Blood Loss 21 21
Perforation 21 21
Obstruction/Occlusion 20 20
Post Operative Wound Infection 20 20
Hematoma 18 18
Abdominal Pain 17 17
Electric Shock 15 15
Tissue Damage 15 15
Fistula 14 14
Death 13 13
Urinary Retention 12 12
Sepsis 12 12
Liver Laceration(s) 12 12
Patient Problem/Medical Problem 11 11
Urinary Tract Infection 11 11
Adhesion(s) 10 10
Peritonitis 10 10
Necrosis 8 8
Hematuria 8 8
Wound Dehiscence 8 8
Urinary Incontinence 8 8
Dysphagia/ Odynophagia 7 7
Great Vessel Perforation 7 7
Low Blood Pressure/ Hypotension 6 6

Recalls
Manufacturer Recall Class Date Posted
1 ASPEN SURGICAL II Jun-27-2024
2 Aesculap Inc II Mar-01-2024
3 Baxter Healthcare Corporation II Jul-26-2021
4 Canadian Hospital Specialties Ltd. II Jul-17-2024
5 Carefusion 2200 Inc II Sep-30-2024
6 CooperSurgical, Inc. II Feb-05-2024
7 Covidien LP II Apr-26-2023
8 Covidien, LP II Apr-03-2024
9 Covidien, LP II Apr-12-2023
10 Davol, Inc. II Jul-22-2022
11 Davol, Inc. II Jun-30-2022
12 Genicon, Inc. II May-14-2020
13 Olympus Corporation of the Americas II Apr-22-2020
14 Sharp Medical Products II Apr-06-2021
15 Stryker Corporation II Mar-07-2022
16 Stryker Corporation II Apr-15-2021
17 Surgical Innovations Ltd II Jul-18-2022
18 Surgical Innovations Ltd II May-17-2023
19 Surgical Innovations Ltd II Sep-29-2022
20 UNIMAX MEDICAL SYSTEMS INC II Sep-17-2024
-
-