Cleared Traditional

K950425 - TECOTHANE 55D

K950425 is the FDA 510(k) clearance for TECOTHANE 55D by Medtronic Vascular. It is a Class 2 Neurology device (product code GZF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K950425 · Medtronic Vascular · Neurology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 1995

Decision

76d

Days

Class 2

Risk

K950425 is an FDA 510(k) clearance for the TECOTHANE 55D. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on April 19, 1995 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5870 - 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	K950425 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 02, 1995
Decision Date	April 19, 1995
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

72d faster than avg

Panel avg: 148d · This submission: 76d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 882.5870

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 - GZF Stimulator, Peripheral Nerve, Implanted (pain Relief)

All 19

Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K950425.

MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38

K000105 · Medtronic Vascular · Apr 2000

PERIPHERAL NERVE STIMULATION

K982902 · Medtronic Vascular · Nov 1998

MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX

K960631 · Medtronic Vascular · May 1996

MEDTRONIC MODEL 3990 PNS LEAD

K925952 · Medtronic Vascular · Aug 1993

MODELS 3987 AND 3988 RESUME LEAD FOR PNS

K920567 · Medtronic Vascular · May 1992

MODEL 3587A RESUME II LEAD

K915540 · Medtronic Vascular · Jan 1992

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 K950425

Medtronic Vascular

Minneapolis, MN · US

DAVID H MUELLER

Regulatory profile

475 submissions 453 cleared

95% clearance rate · Active in Neurology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

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.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,730

Regulatory data since 1976

FDA monthly sync Active