FDA 510(k)

Newclip Patient-matched instrumentation non sterile PSI

Número K: K243912 · 2025-02-13

Data da decisão2025-02-13

Código do produtoPBF

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Newclip Patient-matched instrumentation non sterile PSI is the device name listed in this FDA 510(k) record. The listed applicant is Newclip Technics. It received FDA 510(k) clearance on 2025-02-13 under 510(k) number K243912. The device is classified under product code PBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Newclip Patient-matched instrumentation non sterile PSI?

Newclip Patient-matched instrumentation non sterile PSI is a medical device that received FDA 510(k) clearance on 2025-02-13. The listed applicant is Newclip Technics. The 510(k) number is K243912.

When did Newclip Patient-matched instrumentation non sterile PSI receive FDA 510(k) clearance?

Newclip Patient-matched instrumentation non sterile PSI received FDA 510(k) clearance on 2025-02-13, under 510(k) number K243912.

Who is the listed applicant for Newclip Patient-matched instrumentation non sterile PSI?

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

What is the FDA product code for Newclip Patient-matched instrumentation non sterile PSI?

The FDA product code for Newclip Patient-matched instrumentation non sterile PSI is PBF.

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 Newclip Technics como candidato(a)

K261511Xpert Ankle K261191Alians Elbow S K261038Xpert PFP K253906Xpert Hand K250767Newclip Patient-matched instrumentation non sterile PSI K250155Xpert Knee

Ver todos os 26 dispositivos →

Dispositivos Relacionados (Código: PBF)

K252064MedCAD® AccuStride™ SystemMedcad K250711VSP Orthopedics System3D Systems, Inc.K242603MyPAO SA guidesMedacta International S.A.K251709MedCAD® AccuStride™ SystemMedcad K250394Fine TTO™Bodycad Laboratories, Inc.K250767Newclip Patient-matched instrumentation non sterile PSINewclip Technics

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.