AutoCap RX— 510(k) K210353

Substantially Equivalent

Boston Scientific Corporation

FDA 510(k) clearance K210353 for AutoCap RX, Substantially Equivalent on 2021-05-06. Applicant: Boston Scientific Corporation. Device class: 2.

Clearance details

Applicant: Boston Scientific Corporation
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-02-08
Decision date: 2021-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marlboro, 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.