FDA 510(k)

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women

Número K: K252943 · 2026-04-01

Data da decisão2026-04-01

Código do produtoEZD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2026-04-01 under 510(k) number K252943. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is a medical device that received FDA 510(k) clearance on 2026-04-01. The listed applicant is Convatec Limited. The 510(k) number is K252943.

When did GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women receive FDA 510(k) clearance?

GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women received FDA 510(k) clearance on 2026-04-01, under 510(k) number K252943.

Who is the listed applicant for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

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; GentleCath Glide Intermittent Catheter; GentleCath Air for Women?

The FDA product code for GentleCath Air for Men; GentleCath Glide Intermittent Catheter; GentleCath Air for Women is EZD.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Outros registros que listam Convatec Limited como candidato(a)

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 K181206GentleCath Glide Intermittent Urinary Catheter K173675Vestido Hidrofibrila AQUACEL Ag+ EXTRA com Fibra de Fortalecimento

Ver todos os 10 dispositivos →

Dispositivos Relacionados (Código: EZD)

K261418Liquick X-treme, Liquick X-treme PlusTeleflex Medical K260737Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Female (CH06 - CH16); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Straight (CH06 - CH18); Cure Aqua™ Ready to Use Hydrophilic Intermittent Catheter Male Coude (CH10 - CH18).Convatec K261658LoFric Origo Pro CoudéWellspect AB K262045Luja SoftColoplast A.S.K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)Hangzhou Jimushi Meditech Co., Ltd.K253295Coude Sleeved IC; Coude Plus Sleeved ICHollister Incorporated

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.