Cleared Traditional

K875284 - MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE

K875284 is an FDA 510(k) clearance for MEDTRONIC SNAP EASE MODEL 7795 CUTANEOU..., 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 35-day FDA review.

K875284 · Medtronic Vascular · Neurology device
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Jan 1988
Decision
35d
Days
Class 2
Risk

K875284 is an FDA 510(k) clearance for the MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 28, 1988 after a review of 35 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.

FDA 510(k) Submission Details - K875284

510(k) Number K875284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1987
Decision Date January 28, 1988
Days to Decision 35 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
114d faster than avg
Panel avg: 149d · This submission: 35d
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 439
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K875284.
DURADERM BUTTERFLY
K881343 · Sentry Medical Products, Inc. · May 1988
TENS ELECTRODE SNAP TYPE, DISPOSA., SELF-ADHERING
K880649 · Labeltape Meditect, Inc. · Mar 1988
TRANSCUTANEOUS ELECTRIC NERVE STIMULATION (TENS)
K874469 · Axelgaard Mfg. Co., Ltd. · Jan 1988
DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE
K874735 · Dantec Electronics, Inc. · Jan 1988
ELEC-TIP
K873298 · Etymotic Research · Nov 1987
PT-100-30 SOMATOSENSORY STIMULATING ELECTRODE
K874075 · Weaver & Co. · Oct 1987
K875284 · MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE
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