Cleared Traditional

K171366 - Receiver Kit

K171366 is an FDA 510(k) clearance for Receiver Kit, manufactured by Stimwave Technologies Inc., Dba Stimq, LLC. The device is a Class 2 Neurology device with product code GZF cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K171366 · Stimwave Technologies Inc., Dba Stimq, LLC · Neurology device
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Aug 2017
Decision
87d
Days
Class 2
Risk

K171366 is an FDA 510(k) clearance for the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, SWAG Kit, SWAG.... Classified as Stimulator, Peripheral Nerve, Implanted (pain Relief) (product code GZF), Class II - Special Controls.

Submitted by Stimwave Technologies Inc., Dba Stimq, LLC (Fort Lauderdale, US). The FDA issued a Cleared decision on August 4, 2017 after a review of 87 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 Stimwave Technologies Inc., Dba Stimq, LLC devices

FDA 510(k) Submission Details - K171366

510(k) Number K171366 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2017
Decision Date August 04, 2017
Days to Decision 87 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
61d faster than avg
Panel avg: 148d · This submission: 87d
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 K171366.
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