510(k) K212582
- Device
- SpyGlass Discover Balloon Dilation Catheter
- Applicant
- Boston Scientific Corporation
- 510(k) number
- K212582
- Product code
- GCA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-05-06
- Date received
- 2021-08-16
- Regulation
- 876.5010
- Classification name
- Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laura Kuroski
- Address
- 100 Boston Scientific Way Marlboro MA US 01752 01752
FDA Registration Numbers#
- 3010155661
- 2183744
- 3006621103
- 3003898360
- 2015691
- 2528981
- 3030733800
- 3010288205
- 1320894
- 3010273872
- 8022978
- 3005099803
- 3002807314
- 3030446844
- 3014222368
- 1000121056
- 1037905
- 1000393132
- 3032916632
- 2027111
- 3013526170
- 3009051888
- 1820334
- 3006082230
- 2648045
- 3011137372
- 3012494290
- 1319639
- 2126666
- 1018233
- 9681477
- 3013557562
- 9710641
- 9681260
- 3010041511
Source Documents#
Other 510(k) Records For Product Code GCA #
| 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-23-10/13/16-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 |
| 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 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases