Disposable Endoscope Valves System— 510(k) K232244

Name: FDA 510(k) clearance K232244
Creator: U.S. Food and Drug Administration
Published: 2023-11-29

Substantially Equivalent

Changzhou Endoclean Medical Device Co., Ltd.

FDA 510(k) clearance K232244 for Disposable Endoscope Valves System, Substantially Equivalent on 2023-11-29. Applicant: Changzhou Endoclean Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Endoclean Medical Device Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2023-07-28
Decision date: 2023-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, CN

Download summary PDF View on FDA.gov ↗

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