FDA 510(k)

MR Conditional Cup Electrodes

Número K: K254183 · 2026-05-07

Data da decisão2026-05-07

Código do produtoGXY

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

MR Conditional Cup Electrodes is the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2026-05-07 under 510(k) number K254183. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MR Conditional Cup Electrodes?

MR Conditional Cup Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-07. The listed applicant is Technomed Europe. The 510(k) number is K254183.

When did MR Conditional Cup Electrodes receive FDA 510(k) clearance?

MR Conditional Cup Electrodes received FDA 510(k) clearance on 2026-05-07, under 510(k) number K254183.

Who is the listed applicant for MR Conditional Cup Electrodes?

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

What is the FDA product code for MR Conditional Cup Electrodes?

The FDA product code for MR Conditional Cup Electrodes is GXY.

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 Technomed Europe como candidato(a)

K253581Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005)K241045Disposable Subdermal Needle Electrode, Corkscrew

Dispositivos Relacionados (Código: GXY)

K262654Dexus Prosthetic System (MSL2, MSR2)Zhejiang Qiangnao Technology Co.,Ltd K260578Ambu® NeurolineTM Copo MRI/CT (Modelos 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Copo MRI/CT-conjunto (Modelos 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Copo MRI/CT-mini conjunto (Modelos 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/S K261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave Corporation K253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim Sirketi K252439Tutamen Autoadesivo EletródioDongguan Tutamen Metalwork Co., Ltd.

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.