GCA · Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Gastroenterology, Urology · 21 CFR 876.5010 · Class 2
Overview
| Product Code | GCA |
|---|---|
| Device Name | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Regulation | 21 CFR 876.5010 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.
Classification Rationale
Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
Cleared Devices (25)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Feb 26, 2024 | SESE |
| K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | May 6, 2022 | SESE |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | Apr 27, 2021 | SESE |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | May 1, 2020 | SESE |
| K200247 | Fusion Quattro Extraction Balloon | Wilson-Cook Medical, Inc. | Feb 27, 2020 | SESE |
| K193344 | Tri-Ex Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | Dec 13, 2019 | SESE |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple Sizing | Wilson-Cook Medical, Inc. | Jul 6, 2018 | SESE |
| K173414 | Advance Biliary Balloon Catheter | Cook Incorporated | Jun 22, 2018 | SESK |
| K170292 | Tri-Ex Extraction Balloon With Multiple Sizing | Wilson-Cook Medical, Inc. | Sep 20, 2017 | SESE |
| K063677 | FUSION QUATTRO EXTRACTION BALLOON XL | Wilson-Cook Medical, Inc. | Jan 5, 2007 | SESE |
| K040129 | TRI-EX EXTRACTION BALLOON WITH MULTIPLE SIZING | Wilson-Cook Medical, Inc. | Feb 27, 2004 | SESE |
| K011018 | TAUT BALLOON CATHETER, MODEL 50640 | Taut, Inc. | Jun 22, 2001 | SESE |
| K980917 | ALL SLICONE DRAINAGE, PENROSE DRAIN, CWV DRAIN, THORACIC DRAIN TUBES AND CWV RESERVOIR | Fortune Medical Instrument Corp. | May 27, 1998 | SESE |
| K953951 | WILSON-COOK TRIPLE LUMEN BALLOON STONE EXTRACTOR | Wilson-Cook Medical, Inc. | Sep 19, 1995 | SESE |
| K931619 | MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER | Boston Scientific Corp | Aug 20, 1993 | SESE |
| K920342 | BARD STONE REMOVAL BALLOON CATHETER | C.R. Bard, Inc. | Aug 26, 1992 | SESE |
| K915129 | CATHETER WITH INTRODUCER AND SYRINGES | Utah Pioneer Medical, Inc. | Apr 8, 1992 | SESK |
| K915343 | URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER | Uresil Corp. | Mar 31, 1992 | SESE |
| K914755 | DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT | Davol, Inc. | Mar 30, 1992 | SESK |
| K915506 | LAPAROSCOPIC CHOLANGIOGRAM CATHETER KIT | United States Endoscopy Group, Inc. | Mar 6, 1992 | SESK |
| K913294 | SURGITEK(R) LAPAROSCOPIC CHOLANGIOGRAM KIT | Surgitek Medical Engineering Corp. | Oct 4, 1991 | SESE |
| K911487 | LAPAROSCOPIC CHOLANGIOCATH | United States Endoscopy Group, Inc. | Aug 14, 1991 | SESE |
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | Cathlab Corp. | Aug 2, 1991 | SESE |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | Applied Vascular Devices, Inc. | Apr 18, 1991 | SESE |
| K772292 | T-TUBE WHELAN-MOSS | Davol, Inc. | Dec 20, 1977 | SESE |
Top Applicants
- Wilson-Cook Medical, Inc. — 7 clearances
- United States Endoscopy Group, Inc. — 2 clearances
- Davol, Inc. — 2 clearances
- Utah Pioneer Medical, Inc. — 1 clearance
- Uresil Corp. — 1 clearance
