Cleared Traditional

K180981 - Stimulator Kit

K180981 is the FDA 510(k) clearance for Stimulator Kit by Stimwave Technologies Incorporated. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K180981 · Stimwave Technologies Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2018
Decision
159d
Days
Class 2
Risk

K180981 is an FDA 510(k) clearance for the Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Stimwave Technologies Incorporated (Pompano Beach, US). The FDA issued a Cleared decision on September 19, 2018 after a review of 159 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Stimwave Technologies Incorporated devices

Submission Details

510(k) Number K180981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date September 19, 2018
Days to Decision 159 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
11d slower than avg
Panel avg: 148d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 74
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K180981.
Nalu Lead Blank (50cm)
K190960 · Boston Scientific Neuromodulation · Jul 2019
Freedom Spinal Cord Stimulator (SCS) System
K182720 · Stimwave Technologies Incorporated · Mar 2019
Nalu Neurostimulation System
K183047 · Boston Scientific Neuromodulation · Mar 2019
SWIFT-LOCK ANCHOR
K140272 · St Jude Medical · May 2014
MULTI LEAD TRIAL CABLE
K130545 · St Jude Medical · Jun 2013
RAPID PROGRAMMER
K113611 · St Jude Medical · Apr 2012