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FDA 510(k)

ANDORATE® Valve Kit

K-Number: K232118 · 2023-10-16

ApplicantGa Health Company Limited
Decision Date2023-10-16
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ANDORATE® Valve Kit is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2023-10-16 under approval number K232118. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDORATE® Valve Kit?

ANDORATE® Valve Kit is a medical device that received FDA 510(k) clearance on 2023-10-16. It is manufactured by Ga Health Company Limited. The 510(k) number is K232118.

When was ANDORATE® Valve Kit approved by the FDA?

ANDORATE® Valve Kit received FDA 510(k) clearance on 2023-10-16, under approval number K232118.

What company makes ANDORATE® Valve Kit?

ANDORATE® Valve Kit is manufactured by Ga Health Company Limited.

What is the FDA product code for ANDORATE® Valve Kit?

The FDA product code for ANDORATE® Valve Kit is ODC.

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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.

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