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FDA 510(k)

STERILE SUBDERMAL NEEDLE ELECTRODES

K-Number: K010019 · 2001-03-19

ApplicantNicolet Biomedical, Inc.
Decision Date2001-03-19
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

STERILE SUBDERMAL NEEDLE ELECTRODES is the device name listed in this FDA 510(k) record. The listed applicant is Nicolet Biomedical, Inc.. It received FDA 510(k) clearance on 2001-03-19 under 510(k) number K010019. 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 STERILE SUBDERMAL NEEDLE ELECTRODES?

STERILE SUBDERMAL NEEDLE ELECTRODES is a medical device that received FDA 510(k) clearance on 2001-03-19. The listed applicant is Nicolet Biomedical, Inc.. The 510(k) number is K010019.

When did STERILE SUBDERMAL NEEDLE ELECTRODES receive FDA 510(k) clearance?

STERILE SUBDERMAL NEEDLE ELECTRODES received FDA 510(k) clearance on 2001-03-19, under 510(k) number K010019.

Who is the listed applicant for STERILE SUBDERMAL NEEDLE ELECTRODES?

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

What is the FDA product code for STERILE SUBDERMAL NEEDLE ELECTRODES?

The FDA product code for STERILE SUBDERMAL NEEDLE ELECTRODES is GXZ.

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Other records listing Nicolet Biomedical, Inc. as applicant

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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

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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