SpeediCath Compact Set — 510(k) de la FDA K200820

Resumen del dispositivo

SpeediCath Compact Set is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2020-11-13 under 510(k) number K200820. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the SpeediCath Compact Set?

SpeediCath Compact Set is a medical device that received FDA 510(k) clearance on 2020-11-13. The listed applicant is Coloplast. The 510(k) number is K200820.

When did SpeediCath Compact Set receive FDA 510(k) clearance?

SpeediCath Compact Set received FDA 510(k) clearance on 2020-11-13, under 510(k) number K200820.

Who is the listed applicant for SpeediCath Compact Set?

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

What is the FDA product code for SpeediCath Compact Set?

The FDA product code for SpeediCath Compact Set is GBM.

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Dispositivos relacionados (Código: GBM)

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.

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K213283GentleCath Air for Men Hydrophilic Intermittent Urinary CatheterConvatec Limited K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.

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.