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 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
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  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
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
Q3 MEDICAL USA, LLC (C/O Q3 MEDICAL DEVICES LTD.)
  SUBSTANTIALLY EQUIVALENT 1
S&G BIOTECH, INC.
  SE - WITH LIMITATIONS 2
SOFTAC MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SE - WITH LIMITATIONS 3

MDR Year MDR Reports MDR Events
2021 2297 2304
2022 1749 1759
2023 1615 1639
2024 1948 1956
2025 1944 1944
2026 283 283

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2156 2159
Break 1063 1069
Adverse Event Without Identified Device or Use Problem 999 1003
Improper or Incorrect Procedure or Method 930 933
Burst Container or Vessel 600 600
Material Deformation 545 551
Material Puncture/Hole 517 520
Detachment of Device or Device Component 416 419
Difficult to Remove 395 401
Migration 350 352
Positioning Failure 350 350
Off-Label Use 348 352
Device Dislodged or Dislocated 323 325
Leak/Splash 319 320
Use of Device Problem 301 304
Dent in Material 273 273
Difficult to Advance 264 265
Activation, Positioning or Separation Problem 262 266
Material Twisted/Bent 251 253
Activation Failure 246 249
Inflation Problem 215 215
Premature Activation 155 155
Fracture 155 157
Difficult or Delayed Positioning 153 153
Failure to Advance 148 148
Entrapment of Device 129 129
Material Split, Cut or Torn 120 120
Material Integrity Problem 101 102
Fluid/Blood Leak 96 98
Material Separation 84 88
Positioning Problem 73 73
Physical Resistance/Sticking 71 73
Defective Device 69 69
Deformation Due to Compressive Stress 68 69
Crack 66 66
Failure to Deflate 58 58
Obstruction of Flow 53 53
Deflation Problem 53 53
Device Damaged Prior to Use 50 51
Stretched 50 51
Mechanical Jam 47 48
Defective Component 40 40
Retraction Problem 38 39
Material Protrusion/Extrusion 37 37
Device Contaminated During Manufacture or Shipping 37 37
Malposition of Device 36 37
Device-Device Incompatibility 35 35
Unsealed Device Packaging 34 34
Appropriate Term/Code Not Available 32 32
Difficult or Delayed Activation 31 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 8432 8460
Insufficient Information 300 306
Obstruction/Occlusion 284 287
Foreign Body In Patient 165 169
Perforation 162 163
No Consequences Or Impact To Patient 127 127
Hemorrhage/Bleeding 113 113
Pancreatitis 88 89
Inflammation 76 76
Pain 74 77
Abdominal Pain 67 67
Restenosis 60 60
Thrombosis/Thrombus 60 60
Vascular Dissection 46 46
No Known Impact Or Consequence To Patient 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Unspecified Infection 38 39
Stenosis 38 40
Fever 36 36
Abscess 35 35
Sepsis 31 31
Hematoma 27 27
Vomiting 25 25
Device Embedded In Tissue or Plaque 22 23
Peritonitis 20 21
Embolism/Embolus 18 18
Pseudoaneurysm 17 18
Unspecified Tissue Injury 17 17
Failure of Implant 16 20
Unspecified Hepatic or Biliary Problem 15 15
Jaundice 15 15
Bowel Perforation 15 15
Nausea 14 14
Fistula 13 13
Bacterial Infection 12 12
Discomfort 12 13
Rupture 11 11
Perforation of Vessels 11 11
Swelling/ Edema 11 11
Cardiac Arrest 10 10
Septic Shock 9 9
Pneumonia 8 8
Ulcer 8 8
Urinary Tract Infection 7 7
Ischemia 7 7
Low Blood Pressure/ Hypotension 7 7
Aneurysm 7 7
Myocardial Infarction 7 7
Gastrointestinal Hemorrhage 7 7
Hyperbilirubinemia 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Sep-23-2025
3 Boston Scientific Corporation II Dec-01-2021
4 Cook Incorporated II Jun-27-2024
5 Cook Incorporated II Apr-12-2024
6 Cordis Corporation II Nov-12-2021
7 Cordis US Corp II Jul-11-2022
8 Hobbs Medical, Inc. II Oct-07-2022
9 Olympus Corporation of the Americas II Oct-25-2024
10 Olympus Corporation of the Americas II Jan-31-2024
11 W.L. Gore & Associates, Inc. II Feb-22-2024
12 W.L. Gore & Associates, Inc. II May-14-2021
13 Wilson-Cook Medical Inc. II Dec-01-2023
-
-