FDA 510(k)

Andorate Universal Endoscope Tip Guard

K-Number: K202838 · 2021-03-05

Decision Date2021-03-05

Product CodeOCU

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Andorate Universal Endoscope Tip Guard is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2021-03-05 under approval number K202838. The device is classified under product code OCU. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Andorate Universal Endoscope Tip Guard?

Andorate Universal Endoscope Tip Guard is a medical device that received FDA 510(k) clearance on 2021-03-05. It is manufactured by Ga Health Company Limited. The 510(k) number is K202838.

When was Andorate Universal Endoscope Tip Guard approved by the FDA?

Andorate Universal Endoscope Tip Guard received FDA 510(k) clearance on 2021-03-05, under approval number K202838.

What company makes Andorate Universal Endoscope Tip Guard?

Andorate Universal Endoscope Tip Guard is manufactured by Ga Health Company Limited.

What is the FDA product code for Andorate Universal Endoscope Tip Guard?

The FDA product code for Andorate Universal Endoscope Tip Guard is OCU.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.