Cleared Traditional

K782137 - MEDTRONIC MODEL 3797 ELECTRODE

K782137 is an FDA 510(k) clearance for MEDTRONIC MODEL 3797 ELECTRODE, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K782137 · Medtronic Vascular · Neurology device
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Feb 1979
Decision
42d
Days
Class 2
Risk

K782137 is an FDA 510(k) clearance for the MEDTRONIC MODEL 3797 ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on February 7, 1979 after a review of 42 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K782137

510(k) Number K782137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1978
Decision Date February 07, 1979
Days to Decision 42 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
106d faster than avg
Panel avg: 148d · This submission: 42d
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 292
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K782137.
MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE
K792351 · Medtronic Vascular · Dec 1979
T.E.N.S.* SINGLE-USE ELECTRODE
K790850 · 3M Company · May 1979
ELECTRODE, ELECTROFLEX
K790316 · Andover Medical, Inc. · Mar 1979
EEG LEAD ASSEMBLY
K781494 · Graphic Controls Corp. · Oct 1978
EAR ELECTRODE-ADULT & PEDIATRIC
K780537 · Life-Tech Instruments, Inc. · Jun 1978
KARAYA ELECTRODES
K771719 · Lectec Corp. · Sep 1977