DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900)— 510(k) K240098

Name: FDA 510(k) clearance K240098
Creator: U.S. Food and Drug Administration
Published: 2024-02-09

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K240098 for DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900), Substantially Equivalent on 2024-02-09. 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: 2024-01-12
Decision date: 2024-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

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