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FDA 510(k)

Gynatrof

K-Number: K232040 · 2024-03-01

ApplicantTyros Biopharma, Inc.
Decision Date2024-03-01
Product CodeNUC
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Gynatrof is a medical device manufactured by Tyros Biopharma, Inc.. It received FDA 510(k) clearance on 2024-03-01 under approval number K232040. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gynatrof?

Gynatrof is a medical device that received FDA 510(k) clearance on 2024-03-01. It is manufactured by Tyros Biopharma, Inc.. The 510(k) number is K232040.

When was Gynatrof approved by the FDA?

Gynatrof received FDA 510(k) clearance on 2024-03-01, under approval number K232040.

What company makes Gynatrof?

Gynatrof is manufactured by Tyros Biopharma, Inc..

What is the FDA product code for Gynatrof?

The FDA product code for Gynatrof is NUC.

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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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