FDA 510(k)

SpeediCath Flex Coude Pro

Número K: K190620 · 2019-07-10

Data da decisão2019-07-10

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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 2019-07-10 under 510(k) number K190620. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the SpeediCath Flex Coude Pro?

SpeediCath Flex Coude Pro is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Coloplast. The 510(k) number is K190620.

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

SpeediCath Flex Coude Pro received FDA 510(k) clearance on 2019-07-10, under 510(k) number K190620.

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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Outros registros que listam Coloplast como candidato(a)

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)

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

Fonte oficial

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