Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B— 510(k) K200769

Name: FDA 510(k) clearance K200769
Creator: U.S. Food and Drug Administration
Published: 2021-01-06

Substantially Equivalent

Wilson Instruments (Sha) Co., Ltd.

FDA 510(k) clearance K200769 for Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B, Substantially Equivalent on 2021-01-06. Applicant: Wilson Instruments (Sha) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Wilson Instruments (Sha) Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-03-25
Decision date: 2021-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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