Cleared Traditional

K936101 - CONMED VERSA-STIM NEUROMUSCULAR STIMULA...

K936101 is an FDA 510(k) clearance for CONMED VERSA-STIM 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 190-day FDA review.

K936101 · Conmedcorp · Neurology device
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Jun 1994
Decision
190d
Days
Class 2
Risk

K936101 is an FDA 510(k) clearance for the CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 190 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Conmedcorp devices

FDA 510(k) Submission Details - K936101

510(k) Number K936101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1993
Decision Date June 30, 1994
Days to Decision 190 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
42d slower than avg
Panel avg: 148d · This submission: 190d
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 K936101.
CUTANEOUS ELECTRODE
K933802 · Cadwell Laboratories, Inc. · Sep 1994
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994
DISPOSABLE TAB ELECTRODE
K933803 · Cadwell Laboratories, Inc. · Jul 1994
CONMED VERSA-STIM INTERFERENTIAL ELECTRODE
K940704 · Conmedcorp · Jun 1994
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co. · Dec 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993