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FDA 510(k)

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE

K-Number: K990100 · 2000-08-02

ApplicantTe ME NA S.A.R.L.
Decision Date2000-08-02
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Te ME NA S.A.R.L.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K990100. 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 POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE?

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Te ME NA S.A.R.L.. The 510(k) number is K990100.

When did POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE receive FDA 510(k) clearance?

POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE received FDA 510(k) clearance on 2000-08-02, under 510(k) number K990100.

Who is the listed applicant for POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE?

The FDA 510(k) record lists Te ME NA S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE?

The FDA product code for POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE 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 Te ME NA S.A.R.L. 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.

K990323TE ME NA POLYSTIM NERVE STIMILATORK002405SPINAL EPIDURAL NEEDLESK991259TE ME NA EPIDURAL CATHETERK990020TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

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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