ANDORATE® Valve Kit
K-Number: K230932 · 2023-07-07
ApplicantGa Health Company Limited
Decision Date2023-07-07
Product CodeOCX
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 2023-07-07 under approval number K230932. The device is classified under product code OCX. 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 2023-07-07. It is manufactured by Ga Health Company Limited. The 510(k) number is K230932.
When was ANDORATE® Valve Kit approved by the FDA?
ANDORATE® Valve Kit received FDA 510(k) clearance on 2023-07-07, under approval number K230932.
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 OCX.
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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.