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FDA 510(k)

SpyGlass Discover Balloon Dilation Catheter

K-Number: K212582 · 2022-05-06

ApplicantBoston Scientific Corporation
Decision Date2022-05-06
Product CodeGCA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SpyGlass Discover Balloon Dilation Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-05-06 under approval number K212582. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SpyGlass Discover Balloon Dilation Catheter?

SpyGlass Discover Balloon Dilation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Boston Scientific Corporation. The 510(k) number is K212582.

When was SpyGlass Discover Balloon Dilation Catheter approved by the FDA?

SpyGlass Discover Balloon Dilation Catheter received FDA 510(k) clearance on 2022-05-06, under approval number K212582.

What company makes SpyGlass Discover Balloon Dilation Catheter?

SpyGlass Discover Balloon Dilation Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for SpyGlass Discover Balloon Dilation Catheter?

The FDA product code for SpyGlass Discover Balloon Dilation Catheter is GCA.

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Related Devices (Code: GCA)

K170292Tri-Ex Extraction Balloon With Multiple SizingWilson-Cook Medical, Inc. K173659Howell D.A.S.H Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. K173414Advance Biliary Balloon CatheterCook Incorporated K193344Tri-Ex Extraction Balloon with Multiple SizingWilson-Cook Medical, Inc. K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. K200247Fusion Quattro Extraction BalloonWilson-Cook Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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