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FDA 510(k)

MR Conditional Cup Electrodes

K-Number: K254183 · 2026-05-07

ApplicantTechnomed Europe
Decision Date2026-05-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Technomed Europe as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260578Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)Ambu A/SK261442Charlotte ACC25 Surface Electrode Array; Charlotte ACC25 Reusable Surface Electrode ArrayCadwell Industries, Inc.K261522BioWave BioWrapsBiowave CorporationK253237Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)Elde Medikal Sanayi ve Ticaret Anonim SirketiK252439Tutamen Self Adhesive ElectrodesDongguan Tutamen Metalwork Co., Ltd.K253256myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)Otto Bock Healthcare Products GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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