BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor— 510(k) K210342

Name: FDA 510(k) clearance K210342
Creator: U.S. Food and Drug Administration
Published: 2021-09-03

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K210342 for BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor, Substantially Equivalent on 2021-09-03. Applicant: STERIS Corporation. Device class: 2.

Clearance details

Applicant: STERIS Corporation
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2021-02-05
Decision date: 2021-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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