FDA 510(k)

CanGaroo RM Antibacterial Envelope

Número K: K233991 · 2024-06-14

Data da decisão2024-06-14

Código do produtoFTM

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CanGaroo RM Antibacterial Envelope is the device name listed in this FDA 510(k) record. The listed applicant is Elutia, Inc.. It received FDA 510(k) clearance on 2024-06-14 under 510(k) number K233991. The device is classified under product code FTM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the CanGaroo RM Antibacterial Envelope?

CanGaroo RM Antibacterial Envelope is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Elutia, Inc.. The 510(k) number is K233991.

When did CanGaroo RM Antibacterial Envelope receive FDA 510(k) clearance?

CanGaroo RM Antibacterial Envelope received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233991.

Who is the listed applicant for CanGaroo RM Antibacterial Envelope?

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

What is the FDA product code for CanGaroo RM Antibacterial Envelope?

The FDA product code for CanGaroo RM Antibacterial Envelope is FTM.

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: FTM)

K262406EluPro Antibiotic-Eluting BioEnvelopeBoston Scientific K250598Endoform Reconstructive Template - PLGAAroa Biosurgery , Ltd.K243595OviTex PRS (Long-Term Resorbable)TELA Bio, Inc.K241126OviTex PRSTELA Bio, Inc.K223052Peri-Guard and Supple Peri-GuardSynovis Life Technologies, Inc.K214070OviTex PRS (Long Term Resorbable)Tela Bio

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.