Cleared Traditional

CORDIS STIMUCORD EXTERNAL NEUTRAL STIM (K810319) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K810319 · Cordis Corp. · Neurology device
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Feb 1981
Decision
13d
Days
Class 2
Risk

K810319 is an FDA 510(k) clearance for the CORDIS STIMUCORD EXTERNAL NEUTRAL STIM. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Cordis Corp. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Cordis Corp. devices

Submission Details

510(k) Number K810319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1981
Decision Date February 19, 1981
Days to Decision 13 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
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 70
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K810319.
MEDTRONIC DUAL CHANNEL SPINAL CORD STIM
K812155 · Medtronic Vascular · Oct 1981
MEDTRONIC #3484 PISCES EPIDURAL LEAD
K812154 · Medtronic Vascular · Aug 1981
MYELOSTAT DORSAL CORD STIMULATOR
K811655 · Medtronic Vascular · Jul 1981
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · Medtronic Vascular · Jul 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · Medtronic Vascular · Feb 1980
PISCES-SELECTOR X
K790790 · Medtronic Vascular · May 1979