Panels › Gastroenterology, Urology › Product code GCA · Class 2
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Regulation 876.5010
1510(k)s in 12 months (26 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in GCA
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 8, 2026 | K253013 | Disposable Stone Retrieval Balloon Catheter Zhejiang Soudon Medical Technology Co., Ltd., CN | GCA |
| Feb 26, 2024 | 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 Jiangsu Vedkang Medical Science and Technology Co., Ltd., CN | GCA |
| May 6, 2022 | K212582 | SpyGlass Discover Balloon Dilation Catheter Boston Scientific Corporation | GCA |
| Apr 27, 2021 | K210660 | Stone Retrieval Balloon Catheter Anrei Medical (Hangzhou) Co., Ltd., CN | GCA |
| May 1, 2020 | K200173 | Stone Retrieval Balloon Hangzhou AGS MedTech Co., Ltd., CN | GCA |
| Feb 27, 2020 | K200247 | Fusion Quattro Extraction Balloon Wilson-Cook Medical, Inc. | GCA |
| Dec 13, 2019 | K193344 | Tri-Ex Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| Jul 6, 2018 | K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| Jun 22, 2018 | K173414 | Advance Biliary Balloon Catheter Cook Incorporated | GCA |
| Sep 20, 2017 | K170292 | Tri-Ex Extraction Balloon With Multiple Sizing Wilson-Cook Medical, Inc. | GCA |
| Jan 5, 2007 | K063677 | FUSION QUATTRO EXTRACTION BALLOON XL Wilson-Cook Medical, Inc. | GCA |
| Feb 27, 2004 | K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING Wilson-Cook Medical, Inc. | GCA |
| Jun 22, 2001 | K011018 | TAUT BALLOON CATHETER, MODEL 50640 Taut, Inc. | GCA |
| May 27, 1998 | K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR Fortune Medical Instrument Corp. | GCA |
| Sep 19, 1995 | K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR Wilson-Cook Medical, Inc. | GCA |
| Aug 20, 1993 | K931619 | MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER Boston Scientific Corp | GCA |
| Aug 26, 1992 | K920342 | BARD STONE REMOVAL BALLOON CATHETER C.R. Bard, Inc. | GCA |
| Apr 8, 1992 | K915129 | CATHETER WITH INTRODUCER AND SYRINGES Utah Pioneer Medical, Inc. | GCA |
| Mar 31, 1992 | K915343 | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER Uresil Corp. | GCA |
| Mar 30, 1992 | K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT Davol, Inc. | GCA |
| Mar 6, 1992 | K915506 | LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT United States Endoscopy Group, Inc. | GCA |
| Oct 4, 1991 | K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT Surgitek Medical Engineering Corp. | GCA |
| Aug 14, 1991 | K911487 | LAPAROSCOPIC CHOLANGIOCATH United States Endoscopy Group, Inc. | GCA |
| Aug 2, 1991 | K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER Cathlab Corp. | GCA |
| Apr 18, 1991 | K911181 | INTIMAX(TM) IRRIGATION CATHETER Applied Vascular Devices, Inc. | GCA |
| Dec 20, 1977 | K772292 | T-TUBE WHELAN-MOSS Davol, Inc. | GCA |
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