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FDA 510(k)

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE

K-Number: K040639 · 2004-05-21

ApplicantIsurgical
Decision Date2004-05-21
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Isurgical. It received FDA 510(k) clearance on 2004-05-21 under 510(k) number K040639. 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 ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE?

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE is a medical device that received FDA 510(k) clearance on 2004-05-21. The listed applicant is Isurgical. The 510(k) number is K040639.

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

ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE received FDA 510(k) clearance on 2004-05-21, under 510(k) number K040639.

Who is the listed applicant for ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE?

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

What is the FDA product code for ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE?

The FDA product code for ISURG DISPOSABLE SUBDERMAL NEEDLE ELECTRODE is GXZ.

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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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