Cleared Traditional

K911069 - VERSA-STIM ELECTRODE LINE MODIFIED

K911069 is an FDA 510(k) clearance for VERSA-STIM ELECTRODE LINE MODIFIED, manufactured by Conmedcorp. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K911069 · Conmedcorp · Neurology device
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Jul 1991
Decision
127d
Days
Class 2
Risk

K911069 is an FDA 510(k) clearance for the VERSA-STIM ELECTRODE LINE MODIFIED. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Conmedcorp (Utica, US). The FDA issued a Cleared decision on July 16, 1991 after a review of 127 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 - K911069

510(k) Number K911069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date July 16, 1991
Days to Decision 127 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 148d · This submission: 127d
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 K911069.
MONOTRODE CUTANEOUS ELECTRODE
K915864 · Henley Intl. · Jul 1993
K-STIM
K913031 · Katecho, Inc. · Jan 1992
ELECTRODE USING PROMEON RG-60 SERIES GEL
K915333 · Labeltape Meditect, Inc. · Jan 1992
SPECT.E.N.S. REPOSTION.-E FOAM PIN TYPE TENS ELECT
K902719 · Labeltape Meditect, Inc. · Jul 1990
TBD TENS REUSABLE ELECTRODE
K902195 · Empi · Jun 1990
MODIFIED ISLAND PIN TENS DISPOSABLE ELECTRODE
K901102 · Empi · Mar 1990