Cleared Traditional

K000105 - MEDTRONIC EXTENSION PASSER TUNNELING SY...

Also marketed or referenced as:
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (60 CM),

K000105 is the FDA 510(k) clearance for MEDTRONIC EXTENSION PASSER TUNNELING SY... by Medtronic Vascular. It is a Class 2 Neurology device (product code GZF) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K000105 · Medtronic Vascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
89d
Days
Class 2
Risk

K000105 is an FDA 510(k) clearance for the MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38. Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minnetonka, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 89 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 K000105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2000
Decision Date April 12, 2000
Days to Decision 89 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
59d faster than avg
Panel avg: 148d · This submission: 89d
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 K000105.
StimRouter Neuromodulation System
K190047 · Bioness, Inc. · Oct 2019
IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4
K191435 · Nalu Medical, Inc. · Sep 2019
Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits
K183579 · Boston Scientific Neuromodulation · Mar 2019
PERIPHERAL NERVE STIMULATION
K982902 · Medtronic Vascular · Nov 1998
MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX
K960631 · Medtronic Vascular · May 1996
TECOTHANE 55D
K950425 · Medtronic Vascular · Apr 1995