Disposable Endoscope Valves Set (AF series)— 510(k) K241285

Name: FDA 510(k) clearance K241285
Creator: U.S. Food and Drug Administration
Published: 2024-10-01

Substantially Equivalent

Alton (Shanghai) Medical Instruments Co., Ltd.

FDA 510(k) clearance K241285 for Disposable Endoscope Valves Set (AF series), Substantially Equivalent on 2024-10-01. Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.. Device class: 2.

Clearance details

Applicant: Alton (Shanghai) Medical Instruments Co., Ltd.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-07
Decision date: 2024-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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