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FDA 510(k)

System 83 Revolve Endoscope Washer/Disinfector

N.º K: K241168 · 2024-12-19

SolicitanteWassenburg Medical, Inc.
Fecha de decisión2024-12-19
Código de productoFEB
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

System 83 Revolve Endoscope Washer/Disinfector is the device name listed in this FDA 510(k) record. The listed applicant is Wassenburg Medical, Inc.. It received FDA 510(k) clearance on 2024-12-19 under 510(k) number K241168. The device is classified under product code FEB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the System 83 Revolve Endoscope Washer/Disinfector?

System 83 Revolve Endoscope Washer/Disinfector is a medical device that received FDA 510(k) clearance on 2024-12-19. The listed applicant is Wassenburg Medical, Inc.. The 510(k) number is K241168.

When did System 83 Revolve Endoscope Washer/Disinfector receive FDA 510(k) clearance?

System 83 Revolve Endoscope Washer/Disinfector received FDA 510(k) clearance on 2024-12-19, under 510(k) number K241168.

Who is the listed applicant for System 83 Revolve Endoscope Washer/Disinfector?

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

What is the FDA product code for System 83 Revolve Endoscope Washer/Disinfector?

The FDA product code for System 83 Revolve Endoscope Washer/Disinfector is FEB.

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Dispositivos relacionados (Código: FEB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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