Cleared Traditional

K790790 - PISCES-SELECTOR X

K790790 is the FDA 510(k) clearance for PISCES-SELECTOR X by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K790790 · Medtronic Vascular · Neurology device
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May 1979
Decision
31d
Days
Class 2
Risk

K790790 is an FDA 510(k) clearance for the PISCES-SELECTOR X. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on May 25, 1979 after a review of 31 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 Medtronic Vascular devices

Submission Details

510(k) Number K790790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1979
Decision Date May 25, 1979
Days to Decision 31 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
117d faster than avg
Panel avg: 148d · This submission: 31d
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 74
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K790790.
CORDIS STIMUCORD EXTERNAL NEUTRAL STIM
K810319 · Cordis Corp. · Feb 1981
MYELOSTAT DORSAL CORD STIMULATOR, ETC.
K801384 · Medtronic Vascular · Jul 1980
MEDTRONIC PISCES GENERATION II LEAD KIT
K800193 · Medtronic Vascular · Feb 1980
NEUROLOGICAL SCREENING STIMULATOR M 3623
K780758 · Medtronic Vascular · May 1978
EPIDURAL LEAD - MODEL 3481
K780001 · Medtronic Vascular · Jan 1978