FDA 510(k)

Parafusos de Ancore como Acessórios para Eletródes de Profundidade

Número K: K223276 · 2023-05-18

RequerenteAd-Tech Medical Instrument Corporation

Data da decisão2023-05-18

Código do produtoGZL

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Anchor Bolts as Accessories to Depth Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Ad-Tech Medical Instrument Corporation. It received FDA 510(k) clearance on 2023-05-18 under 510(k) number K223276. The device is classified under product code GZL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Anchor Bolts as Accessories to Depth Electrodes?

Anchor Bolts as Accessories to Depth Electrodes is a medical device that received FDA 510(k) clearance on 2023-05-18. The listed applicant is Ad-Tech Medical Instrument Corporation. The 510(k) number is K223276.

When did Anchor Bolts as Accessories to Depth Electrodes receive FDA 510(k) clearance?

Anchor Bolts as Accessories to Depth Electrodes received FDA 510(k) clearance on 2023-05-18, under 510(k) number K223276.

Who is the listed applicant for Anchor Bolts as Accessories to Depth Electrodes?

The FDA 510(k) record lists Ad-Tech Medical Instrument Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anchor Bolts as Accessories to Depth Electrodes?

The FDA product code for Anchor Bolts as Accessories to Depth Electrodes is GZL.

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 Ad-Tech Medical Instrument Corporation como candidato(a)

K223269Spencer Probe Depth Electrodes K191186Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode K181544Parafuso Anchor (como acessório dos Eletródos de Profundidade)K170442Cranial Drill Bits and Accessories K163355Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes K152769FREMAP ELECTRODE

Ver todos os 8 dispositivos →

Dispositivos Relacionados (Código: GZL)

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.