SpeediCath Standard — 510(k) de la FDA K180258

Resumen del dispositivo

SpeediCath Standard is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K180258. 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 Standard?

SpeediCath Standard is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Coloplast. The 510(k) number is K180258.

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

SpeediCath Standard received FDA 510(k) clearance on 2018-10-25, under 510(k) number K180258.

Who is the listed applicant for SpeediCath Standard?

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 Standard?

The FDA product code for SpeediCath Standard is GBM.

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Otros registros que enlistan a Coloplast como solicitante

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K241028Luja female (20051); Luja female (20052); Luja female (20054); Luja female (20056)K231891Virtue Male Sling System with Alexis Wound Retractor Convenience Kit K230165Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging)K223821Self-Cath Closed System K221401Self-Cath and Self-Cath Plus K222059SpeediCath Flex Set

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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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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.