Disposable Endoscope Valves Kit— 510(k) K222499

Name: FDA 510(k) clearance K222499
Creator: U.S. Food and Drug Administration
Published: 2023-11-22

Substantially Equivalent

Shanghai SeeGen Photoelectric Technology Co., Ltd.

FDA 510(k) clearance K222499 for Disposable Endoscope Valves Kit, Substantially Equivalent on 2023-11-22. Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai SeeGen Photoelectric Technology Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2022-08-18
Decision date: 2023-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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