Andorate Universal Endoscope Tip Guard— 510(k) K202838

Name: FDA 510(k) clearance K202838
Creator: U.S. Food and Drug Administration
Published: 2021-03-05

Substantially Equivalent

Ga Health Company Limited

FDA 510(k) clearance K202838 for Andorate Universal Endoscope Tip Guard, Substantially Equivalent on 2021-03-05. Applicant: Ga Health Company Limited. Device class: 2.

Clearance details

Applicant: Ga Health Company Limited
Product code: Code OCU
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 2020-09-25
Decision date: 2021-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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K951104 — ENDOBOOT1995-04-06
K940780 — SCOPEJOCKEY1994-05-10

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