FDA 510(k)

Vestido Cirúrgico AQUACEL Ag

Número K: K152926 · 2016-01-21

Data da decisão2016-01-21

Código do produtoFRO

DecisãoSubstantially Equivalent

Resumo do dispositivo

AQUACEL Ag Surgical SP Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Convatec Limited. It received FDA 510(k) clearance on 2016-01-21 under 510(k) number K152926. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the AQUACEL Ag Surgical SP Dressing?

AQUACEL Ag Surgical SP Dressing is a medical device that received FDA 510(k) clearance on 2016-01-21. The listed applicant is Convatec Limited. The 510(k) number is K152926.

When did AQUACEL Ag Surgical SP Dressing receive FDA 510(k) clearance?

AQUACEL Ag Surgical SP Dressing received FDA 510(k) clearance on 2016-01-21, under 510(k) number K152926.

Who is the listed applicant for AQUACEL Ag Surgical SP Dressing?

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 AQUACEL Ag Surgical SP Dressing?

The FDA product code for AQUACEL Ag Surgical SP Dressing is FRO. This falls under the Anesthesiology category.

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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 K181206GentleCath Glide Intermittent Urinary Catheter

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