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FDA 510(k)

Andorate Biopsy Valve, Andorate Biopsy Irrigator

K-Number: K200481 · 2020-06-18

ApplicantGa Health Company Limited
Decision Date2020-06-18
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Andorate Biopsy Valve, Andorate Biopsy Irrigator is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2020-06-18 under approval number K200481. 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 Biopsy Valve, Andorate Biopsy Irrigator?

Andorate Biopsy Valve, Andorate Biopsy Irrigator is a medical device that received FDA 510(k) clearance on 2020-06-18. It is manufactured by Ga Health Company Limited. The 510(k) number is K200481.

When was Andorate Biopsy Valve, Andorate Biopsy Irrigator approved by the FDA?

Andorate Biopsy Valve, Andorate Biopsy Irrigator received FDA 510(k) clearance on 2020-06-18, under approval number K200481.

What company makes Andorate Biopsy Valve, Andorate Biopsy Irrigator?

Andorate Biopsy Valve, Andorate Biopsy Irrigator is manufactured by Ga Health Company Limited.

What is the FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator?

The FDA product code for Andorate Biopsy Valve, Andorate Biopsy Irrigator 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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