Cleared Traditional

K990100 - POLYMEDIC UPA NERVE STIMULATION NEEDLE

Also marketed or referenced as:
POLYMEDIC UPC NERVE STIMULATION NEEDLE

K990100 is an FDA 510(k) clearance for POLYMEDIC UPA NERVE STIMULATION NEEDLE, manufactured by Te ME NA S.A.R.L.. The device is a Class 2 Neurology device with product code GXZ cleared through the Traditional 510(k) pathway after a 576-day FDA review.

K990100 · Te ME NA S.A.R.L. · Neurology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
576d
Days
Class 2
Risk

K990100 is an FDA 510(k) clearance for the POLYMEDIC UPA NERVE STIMULATION NEEDLE. Classified as Electrode, Needle (product code GXZ), Class II - Special Controls.

Submitted by Te ME NA S.A.R.L. (Oldsmar, US). The FDA issued a Cleared decision on August 2, 2000 after a review of 576 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1350 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

FDA 510(k) Submission Details - K990100

510(k) Number K990100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date August 02, 2000
Days to Decision 576 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
427d slower than avg
Panel avg: 149d · This submission: 576d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXZ Device Classification - Class 2, Special Controls

Product Code GXZ Electrode, Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - GXZ Electrode, Needle

All 52
Devices cleared under the same product code (GXZ) and FDA review panel - the closest regulatory comparables to K990100.
SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY, MODELS PRO-E12SAF AND DEN-12SAF
K020910 · The Electrode Store, Inc. · Jul 2002
DETACHABLE MONOPOLAR EMG NEEDLE, MODELS 610-725, 610-737, 610-637, 610-744, 610-650, 610-570
K021118 · Class A Ent. · May 2002
STERILE SUBDERMAL NEEDLE ELECTRODES
K010019 · Nicolet Biomedical, Inc. · Mar 2001
ACCUGUIDE MUSCLE INJECTION MONITOR
K990793 · Medtronic Xomed · Oct 1999
NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODES
K983597 · Medicotest, Inc. · Jan 1999
DISPOSABLE NEEDLE ELECTRODE (ALM), DISPOSABLE NEEDLE ELECTRODE (DLM)
K974119 · Jack'S Electrodes · Jan 1998
K990100 · POLYMEDIC UPA NERVE STIMULATION NEEDLE
Download PDF Te ME NA S.A.R.L.