Cleared Traditional

K180981 - Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit

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

K180981 · Stimwave Technologies Incorporated · Neurology device
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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

FDA 510(k) Submission Details - K180981

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.

GZB Device Classification - Class 2, Special Controls

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 117
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
Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
K172644 · Stimwave Technologies Incorporated · Nov 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K170141 · Stimwave Technologies Incorporated · May 2017
Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit
K162161 · Stimwave Technologies Incorporated · Dec 2016