FDA Product Code
FDA Product Code GCA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5010
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon Catheter | Zhejiang Soudon Medical Technology Co., Ltd. | 2026-05-08 | Traditional | PDF ↗ |
| 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-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) | Jiangsu Vedkang Medical Science and Technology Co., Ltd. | 2024-02-26 | Traditional | PDF ↗ |
| K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | 2022-05-06 | Traditional | PDF ↗ |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | 2021-04-27 | Traditional | PDF ↗ |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | 2020-05-01 | Traditional | PDF ↗ |
| K200247 | Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. | 2020-02-27 | Special | PDF ↗ |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2019-12-13 | Special | PDF ↗ |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | 2018-07-06 | Special | PDF ↗ |
| K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | 2018-06-22 | Traditional | PDF ↗ |
| K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | 2017-09-20 | Special | PDF ↗ |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Wilson-Cook Medical, Inc. | 2007-01-05 | Special | PDF ↗ |
| K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | Wilson-Cook Medical, Inc. | 2004-02-27 | Special | PDF ↗ |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | Taut, Inc. | 2001-06-22 | Traditional | PDF ↗ |
| K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | Fortune Medical Instrument Corp. | 1998-05-27 | Traditional | PDF ↗ |
| K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR | Wilson-Cook Medical, Inc. | 1995-09-19 | Traditional | PDF ↗ |
| K931619 | MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER | Boston Scientific Corp | 1993-08-20 | Traditional | PDF ↗ |
| K920342 | BARD STONE REMOVAL BALLOON CATHETER | C.R. Bard, Inc. | 1992-08-26 | Traditional | PDF ↗ |
| K915129 | CATHETER WITH INTRODUCER AND SYRINGES | Utah Pioneer Medical, Inc. | 1992-04-08 | Traditional | PDF ↗ |
| K915343 | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Uresil Corp. | 1992-03-31 | Traditional | PDF ↗ |
| K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT | Davol, Inc. | 1992-03-30 | Traditional | PDF ↗ |
| K915506 | LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT | United States Endoscopy Group, Inc. | 1992-03-06 | Traditional | PDF ↗ |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Surgitek Medical Engineering Corp. | 1991-10-04 | Traditional | PDF ↗ |
| K911487 | LAPAROSCOPIC CHOLANGIOCATH | United States Endoscopy Group, Inc. | 1991-08-14 | Traditional | PDF ↗ |
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | Cathlab Corp. | 1991-08-02 | Traditional | PDF ↗ |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | Applied Vascular Devices, Inc. | 1991-04-18 | Traditional | PDF ↗ |
| K772292 | T-TUBE WHELAN-MOSS | Davol, Inc. | 1977-12-20 | Traditional | PDF ↗ |
Product code GCA · Class II · Gastroenterology, Urology. Data: openFDA.