FDA 510(k)

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter

N.º K: K213283 · 2022-06-22

Fecha de decisión2022-06-22

Código de productoGBM

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

GentleCath Air for Men Hydrophilic 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 2022-06-22 under 510(k) number K213283. 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 GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is a medical device that received FDA 510(k) clearance on 2022-06-22. The listed applicant is Convatec Limited. The 510(k) number is K213283.

When did GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter receive FDA 510(k) clearance?

GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter received FDA 510(k) clearance on 2022-06-22, under 510(k) number K213283.

Who is the listed applicant for GentleCath Air for Men Hydrophilic 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 Air for Men Hydrophilic Intermittent Urinary Catheter?

The FDA product code for GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter is GBM.

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Otros registros que enlistan a Convatec Limited como solicitante

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 K190114Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector)K180205Sistema de Terapia de Heridas de Presión Negativa AVELLE K181206GentleCath Glide Intermittent Urinary Catheter K173675Vestido hidrófobo AQUACEL Ag+ EXTRA con fibra de refuerzo

Ver todos los 10 dispositivos →

Dispositivos relacionados (Código: GBM)

K241734Wellead® Hydrophilic Intermittent Catheter Ready to Use; Wellead® Hydrophilic Intermittent Catheter CompactWell Lead Medical Co., Ltd.K211436Intermittent Catheter (Not Finalized)Hollister Incorporated K200820SpeediCath Compact SetColoplast K192904SpeediCath Compact SetColoplast K200142SpeediCath SoftColoplast K200134Jimushi Sterile Urethral Catheter for single useHangzhou Jimushi Meditech Co., Ltd.

Fuente oficial

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