FDA 510(k)

RENASYS Touch; RENASYS Y-Connector

Número K: K181822 · 2019-03-21

RequerenteSmith & Nephew Medical Limited

Data da decisão2019-03-21

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS Touch; RENASYS Y-Connector is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical Limited. It received FDA 510(k) clearance on 2019-03-21 under 510(k) number K181822. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RENASYS Touch; RENASYS Y-Connector?

RENASYS Touch; RENASYS Y-Connector is a medical device that received FDA 510(k) clearance on 2019-03-21. The listed applicant is Smith & Nephew Medical Limited. The 510(k) number is K181822.

When did RENASYS Touch; RENASYS Y-Connector receive FDA 510(k) clearance?

RENASYS Touch; RENASYS Y-Connector received FDA 510(k) clearance on 2019-03-21, under 510(k) number K181822.

Who is the listed applicant for RENASYS Touch; RENASYS Y-Connector?

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

What is the FDA product code for RENASYS Touch; RENASYS Y-Connector?

The FDA product code for RENASYS Touch; RENASYS Y-Connector is OMP.

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 Smith & Nephew Medical Limited como candidato(a)

K242146BIOBRANE Temporary Wound Dressing; BIOBRANE Glove K223526Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone na Borda, Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone Sacro, Allevyn Ag+ Adesivo de Gel Antimicrobiano de Silicone Cirúrgico K220964VERSAJET Hydrosurgery System (III)K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large K223041Renasys Edge (66803126)K202783Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing

Ver todos os 21 dispositivos →

Dispositivos Relacionados (Código: OMP)

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building K253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork Medical K254019Wound Geni NPWT SystemBechtel Medical, Inc.

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.