Cleared Traditional

K770447 - EPC INSTICKS

K770447 is an FDA 510(k) clearance for EPC INSTICKS, manufactured by Stimulation Technology, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K770447 · Stimulation Technology, Inc. · Neurology device
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Mar 1977
Decision
7d
Days
Class 2
Risk

K770447 is an FDA 510(k) clearance for the EPC INSTICKS. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Stimulation Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 15, 1977 after a review of 7 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 - K770447

510(k) Number K770447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1977
Decision Date March 15, 1977
Days to Decision 7 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
142d faster than avg
Panel avg: 149d · This submission: 7d
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 K770447.
EAR ELECTRODE-ADULT & PEDIATRIC
K780537 · Life-Tech Instruments, Inc. · Jun 1978
ELECTRODE CAP
K780045 · Electro-Cap Intl., Inc. · Jan 1978
KARAYA ELECTRODES
K771719 · Lectec Corp. · Sep 1977
INS - T.E.N.S.
K770448 · Stimulation Technology, Inc. · Mar 1977
VERI/TRODES
K770323 · Verite Scientific, Inc. · Feb 1977
PREGELLED DISPOSABLE ELECTRODE
K760947 · Texas Instruments, Inc. · Nov 1976
K770447 · EPC INSTICKS
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