SpeediCath Soft — 510(k) de la FDA K200142

Resumen del dispositivo

SpeediCath Soft is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2020-07-30 under 510(k) number K200142. 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 Soft?

SpeediCath Soft is a medical device that received FDA 510(k) clearance on 2020-07-30. The listed applicant is Coloplast. The 510(k) number is K200142.

When did SpeediCath Soft receive FDA 510(k) clearance?

SpeediCath Soft received FDA 510(k) clearance on 2020-07-30, under 510(k) number K200142.

Who is the listed applicant for SpeediCath Soft?

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 Soft?

The FDA product code for SpeediCath Soft is GBM.

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Otros registros que enlistan a Coloplast como solicitante

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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 K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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