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PMA de la FDA

Device, incontinence, mechanical/hydraulic

Número de PMA: P000053 · 2026-09-14

SolicitanteBoston Scientific Corp
Fecha de decisión2026-09-14
Número PMAP000053
Código de productoEZY
Clase del dispositivoClase 3
Especialidad médicaG
Número de regulación21 CFR 8
Comité asesorGU

Resumen del dispositivo

Device, incontinence, mechanical/hydraulic is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code EZY. It was reviewed by the GU advisory panel.

Preguntas frecuentes

What is the Device, incontinence, mechanical/hydraulic?

Device, incontinence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.

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

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

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

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

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

The FDA product code for Device, incontinence, mechanical/hydraulic is EZY.

Ensayos clínicos relacionados

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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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