Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280)— 510(k) K243075

Name: FDA 510(k) clearance K243075
Creator: U.S. Food and Drug Administration
Published: 2024-11-08

Substantially Equivalent

STERIS Corporation

FDA 510(k) clearance K243075 for Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280), Substantially Equivalent on 2024-11-08. 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: 2024-09-27
Decision date: 2024-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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