FDA 510(k)

SpeediCath Compact Set

Número K: K200820 · 2020-11-13

Data da decisão2020-11-13

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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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 K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.

Fonte oficial

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