FDA 510(k)

DuraFuse Clip and Applier System

Número K: K213813 · 2022-07-22

Data da decisão2022-07-22

Código do produtoFZP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

DuraFuse Clip and Applier System is the device name listed in this FDA 510(k) record. The listed applicant is Neuramedica, Inc.. It received FDA 510(k) clearance on 2022-07-22 under 510(k) number K213813. The device is classified under product code FZP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the DuraFuse Clip and Applier System?

DuraFuse Clip and Applier System is a medical device that received FDA 510(k) clearance on 2022-07-22. The listed applicant is Neuramedica, Inc.. The 510(k) number is K213813.

When did DuraFuse Clip and Applier System receive FDA 510(k) clearance?

DuraFuse Clip and Applier System received FDA 510(k) clearance on 2022-07-22, under 510(k) number K213813.

Who is the listed applicant for DuraFuse Clip and Applier System?

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

What is the FDA product code for DuraFuse Clip and Applier System?

The FDA product code for DuraFuse Clip and Applier System is FZP.

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: FZP)

K260677Vessel Closure Device (VCD177213P)Vcd Medical S.R.L.K254231Inno-Hook™ Disposable Clip Appliers (Ligating Clips) and Inno-Hook™ Ligating ClipsTaiwan Surgical Corporation K253781InnoClip Clip ApplierTaiwan Surgical Corporation K253903InnoClip Disposable Clip ApplierTaiwan Surgical Corporation K250643Disposable Polymer Ligation ClipsHangzhou Kangji Medical Instrument Co., Ltd.K251054Hem-o-lok™ PurplePlus™ Large Polymer Ligating ClipsTeleflex Medical

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.