Cleared Traditional

K812704 - NEUROMED SELECTRA #7720

K812704 is an FDA 510(k) clearance for NEUROMED SELECTRA #7720, manufactured by Medtronic Vascular. The device is a Class 2 Neurology device with product code GZJ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K812704 · Medtronic Vascular · Neurology device
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Oct 1981
Decision
26d
Days
Class 2
Risk

K812704 is an FDA 510(k) clearance for the NEUROMED SELECTRA #7720. Classified as Stimulator, Nerve, Transcutaneous, For Pain Relief (product code GZJ), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - 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 - K812704

510(k) Number K812704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1981
Decision Date October 19, 1981
Days to Decision 26 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
123d faster than avg
Panel avg: 149d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZJ Device Classification - Class 2, Special Controls

Product Code GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
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 - GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief

All 602
Devices cleared under the same product code (GZJ) and FDA review panel - the closest regulatory comparables to K812704.
TRANSCUTANEOUS ELEC. NERVE STIMULATOR
K813501 · Empi · Dec 1981
BIO-STIMULATOR, MODEL 400
K813100 · Med-Western Electronics, Inc. · Nov 1981
HEALTH-UP
K812432 · Wfx Industries, Inc. · Nov 1981
TENSMAX
K811499 · Anritsu America Co. · Aug 1981
TENS DEVICE
K812138 · Western Advanced Technology, Inc. · Aug 1981
NEUROGAR III
K812036 · Inter Med Industries, Inc. · Aug 1981
K812704 · NEUROMED SELECTRA #7720
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