Cleared Traditional

K142432 - StimRouter Lead Kit/StimRouter Surgical...

K142432 is an FDA 510(k) clearance for StimRouter Lead Kit/StimRouter Surgical..., manufactured by Bioness, Inc.. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K142432 · Bioness, Inc. · Neurology device
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Feb 2015
Decision
175d
Days
Class 2
Risk

K142432 is an FDA 510(k) clearance for the StimRouter Lead Kit/StimRouter Surgical Tool Kit/StimRouter Clinician Kit/Sti.... Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Bioness, Inc. (Valencia, US). The FDA issued a Cleared decision on February 20, 2015 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bioness, Inc. devices

FDA 510(k) Submission Details - K142432

510(k) Number K142432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date February 20, 2015
Days to Decision 175 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZF Device Classification - Class 2, Special Controls

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 21
Devices cleared under the same product code (GZF) and FDA review panel - the closest regulatory comparables to K142432.
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
RENEW NEUROSTIMULATION SYSTEM
K000852 · Advanced Neuromodulation Systems · Jan 2001
MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38
K000105 · Medtronic Vascular · Apr 2000
PERIPHERAL NERVE STIMULATION
K982902 · Medtronic Vascular · Nov 1998