FDA 510(k)

Gynethotics™ Pessary

Número K: K231786 · 2024-03-06

Data da decisão2024-03-06

Código do produtoHHW

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Gynethotics™ Pessary is the device name listed in this FDA 510(k) record. The listed applicant is Cosm Medical. It received FDA 510(k) clearance on 2024-03-06 under 510(k) number K231786. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Gynethotics™ Pessary?

Gynethotics™ Pessary is a medical device that received FDA 510(k) clearance on 2024-03-06. The listed applicant is Cosm Medical. The 510(k) number is K231786.

When did Gynethotics™ Pessary receive FDA 510(k) clearance?

Gynethotics™ Pessary received FDA 510(k) clearance on 2024-03-06, under 510(k) number K231786.

Who is the listed applicant for Gynethotics™ Pessary?

The FDA 510(k) record lists Cosm Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Gynethotics™ Pessary?

The FDA product code for Gynethotics™ Pessary is HHW.

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Fonte oficial

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