FDA 510(k)

Endo SmartCap

N.º K: K223040 · 2023-03-01

Fecha de decisión2023-03-01

Código de productoFAJ

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Endo SmartCap is the device name listed in this FDA 510(k) record. The listed applicant is Medivators, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) number K223040. The device is classified under product code FAJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Endo SmartCap?

Endo SmartCap is a medical device that received FDA 510(k) clearance on 2023-03-01. The listed applicant is Medivators, Inc.. The 510(k) number is K223040.

When did Endo SmartCap receive FDA 510(k) clearance?

Endo SmartCap received FDA 510(k) clearance on 2023-03-01, under 510(k) number K223040.

Who is the listed applicant for Endo SmartCap?

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

What is the FDA product code for Endo SmartCap?

The FDA product code for Endo SmartCap is FAJ.

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Fuente oficial

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