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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 the device name listed in this FDA 510(k) record. The listed applicant is Technomed Europe. It received FDA 510(k) clearance on 2024-12-11 under 510(k) 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. The listed applicant is Technomed Europe. The 510(k) number is K241045.

When did Disposable Subdermal Needle Electrode, Corkscrew receive FDA 510(k) clearance?

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

Who is the listed applicant for Disposable Subdermal Needle Electrode, Corkscrew?

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 Disposable Subdermal Needle Electrode, Corkscrew?

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

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.

K254183MR Conditional Cup ElectrodesK253581Disposable 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)

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.

K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLCK161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.

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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