Cleared Traditional

K950425 - TECOTHANE 55D (FDA 510(k) Clearance)

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

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
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 23
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K950425.
StimTrial Neuromodulation System
K243782 · Bioventus, LLC · Jul 2025
TalisMann Neuromodulation System
K243678 · Bioventus, LLC · Jul 2025
Nalu Neurostimulation System for Peripheral Nerve Stimulation
K232415 · Boston Scientific Neuromodulation · Aug 2024
Freedom Peripheral Nerve Stimulator (PNS) System
K233162 · Curonix · Jun 2024