FDA 510(k)

Gynatrof

Número K: K232040 · 2024-03-01

Data da decisão2024-03-01

Código do produtoNUC

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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

Perguntas frequentes

What is the Gynatrof?

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

When did Gynatrof receive FDA 510(k) clearance?

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

Who is the listed applicant for Gynatrof?

The FDA 510(k) record lists Tyros Biopharma, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gynatrof?

The FDA product code for Gynatrof is NUC.

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