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FDA 510(k)

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve

K-Number: K230280 · 2023-05-11

ApplicantGa Health Company Limited
Decision Date2023-05-11
Product CodeKTI
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is a medical device manufactured by Ga Health Company Limited. It received FDA 510(k) clearance on 2023-05-11 under approval number K230280. The device is classified under product code KTI. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is a medical device that received FDA 510(k) clearance on 2023-05-11. It is manufactured by Ga Health Company Limited. The 510(k) number is K230280.

When was ANDORATE® Suction Valve and ANDORATE® Biopsy Valve approved by the FDA?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve received FDA 510(k) clearance on 2023-05-11, under approval number K230280.

What company makes ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is manufactured by Ga Health Company Limited.

What is the FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve?

The FDA product code for ANDORATE® Suction Valve and ANDORATE® Biopsy Valve is KTI.

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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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