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FDA 510(k)

Reia pessary

N.º K: K232677 · 2024-05-21

SolicitanteReia, LLC
Fecha de decisión2024-05-21
Código de productoHHW
Comité asesorOB
DecisiónSubstantially Equivalent

Resumen del dispositivo

Reia pessary is the device name listed in this FDA 510(k) record. The listed applicant is Reia, LLC. It received FDA 510(k) clearance on 2024-05-21 under 510(k) number K232677. The device is classified under product code HHW. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Reia pessary?

Reia pessary is a medical device that received FDA 510(k) clearance on 2024-05-21. The listed applicant is Reia, LLC. The 510(k) number is K232677.

When did Reia pessary receive FDA 510(k) clearance?

Reia pessary received FDA 510(k) clearance on 2024-05-21, under 510(k) number K232677.

Who is the listed applicant for Reia pessary?

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

What is the FDA product code for Reia pessary?

The FDA product code for Reia pessary is HHW.

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Fuente oficial

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