Cleared Traditional

K944603 - CONMED VERSA STEM NEUROMUSCULAR STIMULA...

K944603 is an FDA 510(k) clearance for CONMED VERSA STEM NEUROMUSCULAR STIMULA..., manufactured by Conmedcorp. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K944603 · Conmedcorp · Neurology device
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Dec 1994
Decision
87d
Days
Class 2
Risk

K944603 is an FDA 510(k) clearance for the CONMED VERSA STEM NEUROMUSCULAR STIMULATION/TENS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on December 15, 1994 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Conmedcorp devices

FDA 510(k) Submission Details - K944603

510(k) Number K944603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1994
Decision Date December 15, 1994
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 - GXY Electrode, Cutaneous

All 194
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K944603.
DISPOSABLE CUTANEOUS ELECTRODES
K941799 · Bio-Logic Systems Corp. · Feb 1995
EEG CUP ELECTRODE
K933808 · Cadwell Laboratories, Inc. · Dec 1994
RING ELECTRODE
K933805 · Cadwell Laboratories, Inc. · Dec 1994
SMARTBRACE ELECTRODE
K940012 · Medical Devices, Inc. · Dec 1994
ELECTROFLEX
K943126 · Medical Devices, Inc. · Dec 1994
ELECTRODE, CUTANEOUS
K933801 · Cadwell Laboratories, Inc. · Oct 1994