FDA 510(k)

VitaMESH Macroporous PP Surgical Mesh

Número K: K172636 · 2018-04-30

Data da decisão2018-04-30

Código do produtoFTL

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

VitaMESH Macroporous PP Surgical Mesh is the device name listed in this FDA 510(k) record. The listed applicant is Proxy Biomedical , Ltd.. It received FDA 510(k) clearance on 2018-04-30 under 510(k) number K172636. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the VitaMESH Macroporous PP Surgical Mesh?

VitaMESH Macroporous PP Surgical Mesh is a medical device that received FDA 510(k) clearance on 2018-04-30. The listed applicant is Proxy Biomedical , Ltd.. The 510(k) number is K172636.

When did VitaMESH Macroporous PP Surgical Mesh receive FDA 510(k) clearance?

VitaMESH Macroporous PP Surgical Mesh received FDA 510(k) clearance on 2018-04-30, under 510(k) number K172636.

Who is the listed applicant for VitaMESH Macroporous PP Surgical Mesh?

The FDA 510(k) record lists Proxy Biomedical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VitaMESH Macroporous PP Surgical Mesh?

The FDA product code for VitaMESH Macroporous PP Surgical Mesh is FTL.

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

Dispositivos Relacionados (Código: FTL)

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim Production K253125Parietene™ Flat Sheet MeshMedtronic - Sofradim Production K251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim Production K250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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.