FDA 510(k)

Phasix ST Umbilical Hernia Patch

Número K: K243241 · 2025-02-19

RequerenteDavol, Inc., A Subsidiary of C.R. Bard, Inc.

Data da decisão2025-02-19

Código do produtoOWT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Phasix ST Umbilical Hernia Patch is the device name listed in this FDA 510(k) record. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. It received FDA 510(k) clearance on 2025-02-19 under 510(k) number K243241. The device is classified under product code OWT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Phasix ST Umbilical Hernia Patch?

Phasix ST Umbilical Hernia Patch is a medical device that received FDA 510(k) clearance on 2025-02-19. The listed applicant is Davol, Inc., A Subsidiary of C.R. Bard, Inc.. The 510(k) number is K243241.

When did Phasix ST Umbilical Hernia Patch receive FDA 510(k) clearance?

Phasix ST Umbilical Hernia Patch received FDA 510(k) clearance on 2025-02-19, under 510(k) number K243241.

Who is the listed applicant for Phasix ST Umbilical Hernia Patch?

The FDA 510(k) record lists Davol, Inc., A Subsidiary of C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phasix ST Umbilical Hernia Patch?

The FDA product code for Phasix ST Umbilical Hernia Patch is OWT.

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: OWT)

K233661Transorb™ Self-Gripping Resorbable MeshSofradim Production K191749TIGR Matrix Surgical Mesh, TIGR Surgical MeshNovus Scientific AB K191773GORE BIO-A Tissue ReinforcementW. L. Gore & Associates, Inc.K190185Phasix ST Mesh with Open Positioning SystemC.R. Bard, Inc.K173143Phasix ST MeshC.R. Bard, Inc.K163005TIGR Matrix Surgical MeshNovus Scientific AB

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.