FDA 510(k)

Innomed NPWT Silicone Foam Dressing

Número K: K202823 · 2021-12-15

RequerenteZhejiang Longterm Medical Technology Co., Ltd.

Data da decisão2021-12-15

Código do produtoOMP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Innomed NPWT Silicone Foam Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-12-15 under 510(k) number K202823. 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 Innomed NPWT Silicone Foam Dressing?

Innomed NPWT Silicone Foam Dressing is a medical device that received FDA 510(k) clearance on 2021-12-15. The listed applicant is Zhejiang Longterm Medical Technology Co., Ltd.. The 510(k) number is K202823.

When did Innomed NPWT Silicone Foam Dressing receive FDA 510(k) clearance?

Innomed NPWT Silicone Foam Dressing received FDA 510(k) clearance on 2021-12-15, under 510(k) number K202823.

Who is the listed applicant for Innomed NPWT Silicone Foam Dressing?

The FDA 510(k) record lists Zhejiang Longterm Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Innomed NPWT Silicone Foam Dressing?

The FDA product code for Innomed NPWT Silicone Foam Dressing 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 Zhejiang Longterm Medical Technology Co., Ltd. como candidato(a)

K254246LT Antibacterial Foam with Silver Dressing K211571Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit K192478LT Antibacterial Alginate with Silver Dressing K182458Longterm NPWT Foam Dressing Kit

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.