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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stents, drains and dilators for the biliary ducts
Regulation Description Biliary catheter and accessories.
Product CodeFGE
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SE - WITH LIMITATIONS 2
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
S&G BIOTECH INC.
  SE - WITH LIMITATIONS 1
TAEWOONG MEDICAL CO., LTD
  SE - WITH LIMITATIONS 2

MDR Year MDR Reports MDR Events
2020 2181 2181
2021 2297 2297
2022 1749 1749
2023 1622 1622
2024 1952 1952
2025 284 284

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2217 2217
Break 975 975
Improper or Incorrect Procedure or Method 965 965
Adverse Event Without Identified Device or Use Problem 823 823
Material Puncture/Hole 614 614
Burst Container or Vessel 566 566
Off-Label Use 561 561
Material Deformation 532 532
Detachment of Device or Device Component 431 431
Difficult to Remove 408 408
Migration 359 359
Device Dislodged or Dislocated 341 341
Positioning Failure 290 290
Leak/Splash 278 278
Difficult to Advance 278 278
Activation, Positioning or Separation Problem 273 273
Use of Device Problem 269 269
Material Twisted/Bent 240 240
Activation Failure 229 229
Dent in Material 218 218
Premature Activation 171 171
Fracture 170 170
Inflation Problem 161 161
Failure to Advance 141 141
Difficult or Delayed Positioning 137 137
Entrapment of Device 118 118
Material Integrity Problem 107 107
Material Separation 93 93
Material Split, Cut or Torn 87 87
Obstruction of Flow 85 85
Physical Resistance/Sticking 85 85
Positioning Problem 78 78
Deformation Due to Compressive Stress 69 69
Defective Device 68 68
Deflation Problem 66 66
Mechanical Jam 56 56
Appropriate Term/Code Not Available 54 54
Fluid/Blood Leak 54 54
Crack 53 53
Migration or Expulsion of Device 53 53
Stretched 52 52
Device Damaged Prior to Use 50 50
Defective Component 44 44
Unsealed Device Packaging 43 43
Malposition of Device 42 42
Difficult or Delayed Activation 42 42
Failure to Deflate 41 41
Retraction Problem 37 37
Device-Device Incompatibility 36 36
Difficult to Insert 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7005 7005
No Consequences Or Impact To Patient 1569 1569
No Known Impact Or Consequence To Patient 442 442
Obstruction/Occlusion 300 300
Insufficient Information 262 262
Foreign Body In Patient 158 158
Perforation 156 156
Inflammation 133 133
Hemorrhage/Bleeding 126 126
Pancreatitis 96 96
Pain 73 73
Abdominal Pain 68 68
Thrombosis/Thrombus 59 59
No Code Available 52 52
Restenosis 49 49
Vascular Dissection 49 49
No Patient Involvement 43 43
Stenosis 42 42
Occlusion 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Device Embedded In Tissue or Plaque 34 34
Fever 32 32
Abscess 31 31
Unspecified Infection 29 29
Sepsis 29 29
Hematoma 28 28
Failure of Implant 25 25
Jaundice 24 24
Peritonitis 21 21
Pseudoaneurysm 21 21
Vomiting 20 20
No Information 19 19
Bowel Perforation 18 18
Unspecified Tissue Injury 16 16
Embolism/Embolus 16 16
Thrombosis 14 14
Unspecified Hepatic or Biliary Problem 14 14
Cardiac Arrest 13 13
Rupture 13 13
Nausea 13 13
Ischemia 12 12
Perforation of Vessels 12 12
Fistula 12 12
Discomfort 11 11
Septic Shock 11 11
Injury 11 11
Pneumonia 10 10
Stroke/CVA 10 10
Myocardial Infarction 10 10
Blood Loss 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Dec-01-2021
3 Boston Scientific Corporation II Oct-23-2020
4 Boston Scientific Corporation II Sep-12-2020
5 Cook Incorporated II Jun-27-2024
6 Cook Incorporated II Apr-12-2024
7 Cordis Corporation II Nov-12-2021
8 Cordis US Corp II Jul-11-2022
9 Hobbs Medical, Inc. II Oct-07-2022
10 Olympus Corporation of the Americas II Oct-25-2024
11 Olympus Corporation of the Americas II Jan-31-2024
12 W.L. Gore & Associates, Inc. II Feb-22-2024
13 W.L. Gore & Associates, Inc. II May-14-2021
14 Wilson-Cook Medical Inc. II Dec-01-2023
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