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PMA de la FDA

Device, impotence, mechanical/hydraulic

Número de PMA: P000006 · 2026-08-13

SolicitanteColoplast Corp.
Fecha de decisión2026-08-13
Número PMAP000006
Código de productoFHW
Clase del dispositivoClase 3
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorGU

Resumen del dispositivo

Device, impotence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2026-08-13. The device is classified under product code FHW. It was reviewed by the GU advisory panel.

Preguntas frecuentes

What is the Device, impotence, mechanical/hydraulic?

Device, impotence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Coloplast Corp..

When did Device, impotence, mechanical/hydraulic receive FDA 510(k) clearance?

The clearance date for Device, impotence, mechanical/hydraulic can be found in the official FDA records.

Who is the listed applicant for Device, impotence, mechanical/hydraulic?

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

What is the FDA product code for Device, impotence, mechanical/hydraulic?

The FDA product code for Device, impotence, mechanical/hydraulic is FHW.

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Fuente oficial

Ver en la base de datos de la FDA →

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