BioGuard EUS Air/Water and Suction Valves— 510(k) K202104

Name: FDA 510(k) clearance K202104
Creator: U.S. Food and Drug Administration
Published: 2021-01-14

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K202104 for BioGuard EUS Air/Water and Suction Valves, Substantially Equivalent on 2021-01-14. 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: 2020-07-29
Decision date: 2021-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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