FDA 510(k)

GentleCath Glide Intermittent Urinary Catheter

Número K: K181206 · 2018-08-16

Data da decisão2018-08-16

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GentleCath Glide Intermittent Urinary Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2018-08-16 under 510(k) number K181206. 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 GentleCath Glide Intermittent Urinary Catheter?

GentleCath Glide Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2018-08-16. The listed applicant is Convatec Limited. The 510(k) number is K181206.

When did GentleCath Glide Intermittent Urinary Catheter receive FDA 510(k) clearance?

GentleCath Glide Intermittent Urinary Catheter received FDA 510(k) clearance on 2018-08-16, under 510(k) number K181206.

Who is the listed applicant for GentleCath Glide Intermittent Urinary Catheter?

The FDA 510(k) record lists Convatec Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GentleCath Glide Intermittent Urinary Catheter?

The FDA product code for GentleCath Glide Intermittent Urinary Catheter is GBM.

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Outros registros que listam Convatec Limited como candidato(a)

K252943GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14C K213283GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)K180205Sistema de Terapia de Ferida de Pressão Negativa AVELLE K173675Vestido Hidrofibrila AQUACEL Ag+ EXTRA com Fibra de Fortalecimento

Ver todos os 10 dispositivos →

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

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