Cleared Traditional

K800193 - MEDTRONIC PISCES GENERATION II LEAD KIT

K800193 is the FDA 510(k) clearance for MEDTRONIC PISCES GENERATION II LEAD KIT by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K800193 · Medtronic Vascular · Neurology device

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Feb 1980

Decision

Days

Class 2

Risk

K800193 is an FDA 510(k) clearance for the MEDTRONIC PISCES GENERATION II LEAD KIT. 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 February 5, 1980 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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	K800193 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 29, 1980
Decision Date	February 05, 1980
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

141d faster than avg

Panel avg: 148d · This submission: 7d

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 K800193.

MYELOSTAT DORSAL CORD STIMULATOR

K811655 · Medtronic Vascular · Jul 1981

CORDIS STIMUCORD EXTERNAL NEUTRAL STIM

K810319 · Cordis Corp. · Feb 1981

MYELOSTAT DORSAL CORD STIMULATOR, ETC.

K801384 · Medtronic Vascular · Jul 1980

PISCES-SELECTOR X

K790790 · Medtronic Vascular · May 1979

NEUROLOGICAL SCREENING STIMULATOR M 3623

K780758 · Medtronic Vascular · May 1978

EPIDURAL LEAD - MODEL 3481

K780001 · Medtronic Vascular · Jan 1978

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800193

Medtronic Vascular

Walker, MI · US

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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