Cleared Traditional

K162161 - Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit

K162161 is an FDA 510(k) clearance for Receiver 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 136-day FDA review.

K162161 · Stimwave Technologies Incorporated · Neurology device
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Dec 2016
Decision
136d
Days
Class 2
Risk

K162161 is an FDA 510(k) clearance for the Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Anten.... Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Stimwave Technologies Incorporated (Fort Lauderdale, US). The FDA issued a Cleared decision on December 16, 2016 after a review of 136 days - within the typical 510(k) review window.

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 - K162161

510(k) Number K162161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2016
Decision Date December 16, 2016
Days to Decision 136 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
12d faster than avg
Panel avg: 148d · This submission: 136d
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 K162161.
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
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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
Freedom Spinal Cord Stimulator System
K160600 · Stimwave Technologies Incorporated · Aug 2016
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
K150924 · Anchor Innovation Medical (A.I.M.) · Jul 2015
Freedom Spinal Cord Stimulator System
K150517 · Stimwave Technologies Incorporated · Jun 2015