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FDA 510(k)

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE

K-Number: K912783 · 1992-02-05

ApplicantClass A Ent.
Decision Date1992-02-05
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Class A Ent.. It received FDA 510(k) clearance on 1992-02-05 under 510(k) number K912783. 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 MONOPOLAR NEEDLE ELECTRODE?

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 1992-02-05. The listed applicant is Class A Ent.. The 510(k) number is K912783.

When did DISPOSABLE MONOPOLAR NEEDLE ELECTRODE receive FDA 510(k) clearance?

DISPOSABLE MONOPOLAR NEEDLE ELECTRODE received FDA 510(k) clearance on 1992-02-05, under 510(k) number K912783.

Who is the listed applicant for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

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

What is the FDA product code for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE?

The FDA product code for DISPOSABLE MONOPOLAR NEEDLE ELECTRODE is GXZ.

Related Clinical Trials

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.

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Other records listing Class A Ent. 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.

K021118DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570K982053EEG ELECTRODES MODEL 445 SERIES

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.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical 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, LLC

Official Source

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

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