Cleared Traditional

K940704 - CONMED VERSA-STIM INTERFERENTIAL ELECTRODE

K940704 is an FDA 510(k) clearance for CONMED VERSA-STIM INTERFERENTIAL ELECTRODE, manufactured by Conmedcorp. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K940704 · Conmedcorp · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
126d
Days
Class 2
Risk

K940704 is an FDA 510(k) clearance for the CONMED VERSA-STIM INTERFERENTIAL ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmedcorp (Dayton, US). The FDA issued a Cleared decision on June 22, 1994 after a review of 126 days - within the typical 510(k) review window.

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 - K940704

510(k) Number K940704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1994
Decision Date June 22, 1994
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
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 K940704.
GROUND PLATE ELECTRODE
K933807 · Cadwell Laboratories, Inc. · Jul 1994
DISPOSABLE TAB ELECTRODE
K933803 · Cadwell Laboratories, Inc. · Jul 1994
CONMED VERSA-STIM NEUROMUSCULAR STIMULATION ELECTRODE
K936101 · Conmedcorp · Jun 1994
PHOTOSTRESS RECOVERY TESTER
K933814 · Storz Instrument Co. · Dec 1993
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
K-STIM
K913031 · Katecho, Inc. · Jan 1992