SpyGlass Discover Retrieval Basket— 510(k) K203322

Name: FDA 510(k) clearance K203322
Creator: U.S. Food and Drug Administration
Published: 2021-05-26

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K203322 for SpyGlass Discover Retrieval Basket, Substantially Equivalent on 2021-05-26. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 2020-11-12
Decision date: 2021-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlborough, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.