SpeediCath Flex Coude Pro — 510(k) de la FDA K180070

Resumen del dispositivo

SpeediCath Flex Coude Pro is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-02-02 under 510(k) number K180070. 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 Flex Coude Pro?

SpeediCath Flex Coude Pro is a medical device that received FDA 510(k) clearance on 2018-02-02. The listed applicant is Coloplast. The 510(k) number is K180070.

When did SpeediCath Flex Coude Pro receive FDA 510(k) clearance?

SpeediCath Flex Coude Pro received FDA 510(k) clearance on 2018-02-02, under 510(k) number K180070.

Who is the listed applicant for SpeediCath Flex Coude Pro?

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 Flex Coude Pro?

The FDA product code for SpeediCath Flex Coude Pro 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 K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast

Fuente oficial

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