Product code GCA
- Device name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5010
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-05-08 |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-1... | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-26 |
| K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | 2022-05-06 |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-27 |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020-05-01 |
| K200247 | Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. | 2020-02-27 |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2019-12-13 |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2018-07-06 |
| K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | 2018-06-22 |
| K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017-09-20 |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Wilson-Cook Medical, Inc. | 2007-01-05 |
| K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | Wilson-Cook Medical, Inc. | 2004-02-27 |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | Taut, Inc. | 2001-06-22 |
| K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | Fortune Medical Instrument Corp. | 1998-05-27 |
| K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR | Wilson-Cook Medical, Inc. | 1995-09-19 |
| K931619 | MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER | Boston Scientific Corp | 1993-08-20 |
| K920342 | BARD STONE REMOVAL BALLOON CATHETER | C.R. Bard, Inc. | 1992-08-26 |
| K915129 | CATHETER WITH INTRODUCER AND SYRINGES | Utah Pioneer Medical, Inc. | 1992-04-08 |
| K915343 | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Uresil Corp. | 1992-03-31 |
| K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT | Davol, Inc. | 1992-03-30 |
| K915506 | LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT | United States Endoscopy Group, Inc. | 1992-03-06 |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Surgitek Medical Engineering Corp. | 1991-10-04 |
| K911487 | LAPAROSCOPIC CHOLANGIOCATH | United States Endoscopy Group, Inc. | 1991-08-14 |
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | Cathlab Corp. | 1991-08-02 |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | Applied Vascular Devices, Inc. | 1991-04-18 |
| K772292 | T-TUBE WHELAN-MOSS | Davol, Inc. | 1977-12-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06970057571027 | Stone Extraction Balloon | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. | 2026-04-14 |
| 06948318963119 | Anrei | Anrei Medical(HZ) Co.,Ltd. | 2025-01-07 |
| 06948318963102 | Anrei | Anrei Medical(HZ) Co.,Ltd. | 2025-01-07 |
| 14711182608313 | Silicone T Drainage Set With Eyes | FORTUNE MEDICAL INSTRUMENT CORP. | 2023-10-24 |
| 14711182608306 | Silicone T Drainage Set With Eyes | FORTUNE MEDICAL INSTRUMENT CORP. | 2023-10-24 |
| 04711182608309 | Silicone T Drainage Set With Eyes | FORTUNE MEDICAL INSTRUMENT CORP. | 2023-10-24 |
| 04711182608316 | Silicone T Drainage Set With Eyes | FORTUNE MEDICAL INSTRUMENT CORP. | 2023-10-24 |
| 06959664910719 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 16959664910709 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 06959664910757 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 06959664910740 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 06959664910702 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 16959664910716 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 16959664910747 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 16959664910754 | NA | Hangzhou AGS MedTech Co., Ltd. | 2022-10-09 |
| 00191506013516 | SpyGlass™ Discover | BOSTON SCIENTIFIC CORPORATION | 2022-06-03 |
| 00191506013493 | SpyGlass™ Discover | BOSTON SCIENTIFIC CORPORATION | 2022-06-03 |
| 00191506013509 | SpyGlass™ Discover | BOSTON SCIENTIFIC CORPORATION | 2022-06-03 |
| 50195594641434 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-04-12 |
| 10195594641436 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2022-04-12 |
| 10827002588032 | Advance | COOK INCORPORATED | 2021-02-09 |
| 10827002588049 | Advance | COOK INCORPORATED | 2021-02-09 |
| 50690103205119 | FOGARTY | Edwards Lifesciences LLC | 2020-08-31 |
| 50690103205126 | FOGARTY | Edwards Lifesciences LLC | 2020-08-31 |
| 00690103205138 | FOGARTY | Edwards Lifesciences LLC | 2020-08-31 |
| 00690103205121 | FOGARTY | Edwards Lifesciences LLC | 2020-08-31 |
| 00690103205114 | FOGARTY | Edwards Lifesciences LLC | 2020-08-31 |
| 00827002363472 | Advance | COOK INCORPORATED | 2016-09-24 |
| 00816765011959 | NA | US Endoscopy | 2016-09-17 |
| 00816765011942 | NA | US Endoscopy | 2016-09-17 |