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FDA 510(k)

Disposable Subdermal Needle Electrode, Corkscrew

K-Number: K241045 · 2024-12-11

ApplicantTechnomed Europe
Decision Date2024-12-11
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Disposable Subdermal Needle Electrode, Corkscrew is a medical device manufactured by Technomed Europe. It received FDA 510(k) clearance on 2024-12-11 under approval number K241045. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Subdermal Needle Electrode, Corkscrew?

Disposable Subdermal Needle Electrode, Corkscrew is a medical device that received FDA 510(k) clearance on 2024-12-11. It is manufactured by Technomed Europe. The 510(k) number is K241045.

When was Disposable Subdermal Needle Electrode, Corkscrew approved by the FDA?

Disposable Subdermal Needle Electrode, Corkscrew received FDA 510(k) clearance on 2024-12-11, under approval number K241045.

What company makes Disposable Subdermal Needle Electrode, Corkscrew?

Disposable Subdermal Needle Electrode, Corkscrew is manufactured by Technomed Europe.

What is the FDA product code for Disposable Subdermal Needle Electrode, Corkscrew?

The FDA product code for Disposable Subdermal Needle Electrode, Corkscrew is GXZ.

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Other Devices by Technomed Europe

K254183MR Conditional Cup Electrodes 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)

Related Devices (Code: GXZ)

K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl K190801PressOn Electrode HeadsetRhythmlink International, LLC K200984Guardian Needle ElectrodeRhythmlink International, LLC K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.

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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