SpyGlass Discover Balloon Dilation Catheter
FDA 510(k) K212582 · Boston Scientific Corporation
510(k) numberK212582
Submission
- Device name
- SpyGlass Discover Balloon Dilation Catheter
- Applicant
- Boston Scientific Corporation
Marlboro, MA, US - Received
- August 16, 2021
- Decision date
- May 6, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5010
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253013 | Disposable Stone Retrieval Balloon CatheterGCA · Traditional | Zhejiang Soudon Medical Technology Co., Ltd. | 05/08/2026SE |
| K232752 | Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-…GCA · Traditional | Jiangsu Vedkang Medical Science and Technology… | 02/26/2024SE |
| K210660 | Stone Retrieval Balloon CatheterGCA · Traditional | Anrei Medical (Hangzhou) Co., Ltd. | 04/27/2021SE |
| K200173 | Stone Retrieval BalloonGCA · Traditional | Hangzhou AGS MedTech Co., Ltd. | 05/01/2020SE |
| K200247 | Fusion Quattro Extraction BalloonGCA · Special | Wilson-Cook Medical, Inc. | 02/27/2020SE |
| K193344 | Tri-Ex Extraction Balloon with Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 12/13/2019SE |
| K173659 | Howell D.A.S.H Extraction Balloon with Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 07/06/2018SE |
| K173414 | Advance Biliary Balloon CatheterGCA · Traditional | Cook Incorporated | 06/22/2018SESK |
| K170292 | Tri-Ex Extraction Balloon With Multiple SizingGCA · Special | Wilson-Cook Medical, Inc. | 09/20/2017SE |
| K063677 | Fusion Quattro Extraction Balloon XLGCA · Special | Wilson-Cook Medical, Inc. | 01/05/2007SE |
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| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was SpyGlass Discover Balloon Dilation Catheter cleared by the FDA?
SpyGlass Discover Balloon Dilation Catheter (K212582) received a 510(k) decision of Substantially Equivalent on May 6, 2022, 263 days after the submission was received.
What is the product code of K212582?
The FDA product code is GCA – Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection, a Class II (moderate risk) device regulated under 21 CFR 876.5010.