FDA 510(k)

Instrumentos Cirúrgicos Médicos Ace

Número K: K200387 · 2020-07-21

Data da decisão2020-07-21

Código do produtoHAE

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ace Medical Surgical Instruments is the device name listed in this FDA 510(k) record. The listed applicant is Ace Medical. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K200387. The device is classified under product code HAE. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ace Medical Surgical Instruments?

Ace Medical Surgical Instruments is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Ace Medical. The 510(k) number is K200387.

When did Ace Medical Surgical Instruments receive FDA 510(k) clearance?

Ace Medical Surgical Instruments received FDA 510(k) clearance on 2020-07-21, under 510(k) number K200387.

Who is the listed applicant for Ace Medical Surgical Instruments?

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

What is the FDA product code for Ace Medical Surgical Instruments?

The FDA product code for Ace Medical Surgical Instruments is HAE.

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: HAE)

K260446Tontarra Punches and RongeursTontarra Medizintechnik GmbH K242759Geister K-Rex rongeursGeister Medizin Technik GmbH K223596SQ.line KERRISONAesculap, Inc.K230256Rebellion, Phantom Multi-Bite Kerrison RongeurMorpheus AG K221818Rebellion; Phantom Multi-Bite Kerrison RongeurMorpheus AG K210741KLS Martin Neuro RongeursKLS-Martin L.P.

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.