Andorate Biopsy Valve, Andorate Biopsy Irrigator— 510(k) K200481

Name: FDA 510(k) clearance K200481
Creator: U.S. Food and Drug Administration
Published: 2020-06-18

Substantially Equivalent

Ga Health Company Limited

FDA 510(k) clearance K200481 for Andorate Biopsy Valve, Andorate Biopsy Irrigator, Substantially Equivalent on 2020-06-18. Applicant: Ga Health Company Limited. Device class: 2.

Clearance details

Applicant: Ga Health Company Limited
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-02-27
Decision date: 2020-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.