FDA 510(k)

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology

Número K: K251826 · 2025-09-11

Data da decisão2025-09-11

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew Medical, Ltd.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251826. 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 WOUND+ Dressing Kit with AIRLOCK Technology?

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Smith & Nephew Medical, Ltd.. The 510(k) number is K251826.

When did RENASYS WOUND+ Dressing Kit with AIRLOCK Technology receive FDA 510(k) clearance?

RENASYS WOUND+ Dressing Kit with AIRLOCK Technology received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251826.

Who is the listed applicant for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

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

What is the FDA product code for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology?

The FDA product code for RENASYS WOUND+ Dressing Kit with AIRLOCK Technology 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, Ltd. como candidato(a)

K261338RENASYS DYNAFLOW Kit (66807741)K260646RENASYS EDGE (66803126)K243576RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port; RENASYS Gauze Wound Dressing Kit with AIRLOCK Technology and Soft Port K231939Renasys Edge K190756IODOFLEX K190730IODOSORB

Ver todos os 9 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.