Cleared Traditional

K893793 - TENZCARE ELECTRODE 6862

K893793 is an FDA 510(k) clearance for TENZCARE ELECTRODE 6862, manufactured by 3M Company. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K893793 · 3M Company · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
189d
Days
Class 2
Risk

K893793 is an FDA 510(k) clearance for the TENZCARE ELECTRODE 6862. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on November 27, 1989 after a review of 189 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 3M Company devices

FDA 510(k) Submission Details - K893793

510(k) Number K893793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date November 27, 1989
Days to Decision 189 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 148d · This submission: 189d
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 293
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K893793.
BABE-EASE NEONATAL CLOTH ECG ELECTRODE
K896844 · Labeltape Meditect, Inc. · Feb 1990
L.A.S.P. LUMBAR AND SACRAL PAD, REPOSITION. SNAP
K896936 · Labeltape Meditect, Inc. · Jan 1990
MODIFIED ISLAND TENS DISP. ELECTRODE FOR SNAP CONN
K896485 · Empi · Dec 1989
PROMONTORY STIMULATING ELECTRODE
K895081 · Cadwell Laboratories, Inc. · Nov 1989
SPECT.E.N.S. REPOSITIONABLE, PIN TYPE, TENS
K894042 · Labeltape Meditect, Inc. · Aug 1989
SPECT.E.N.S REPOSITIONABLE, SNAP-TYPE, TENS
K894043 · Labeltape Meditect, Inc. · Aug 1989