Cleared Traditional

K160600 - Freedom Spinal Cord Stimulator System

K160600 is an FDA 510(k) clearance for Freedom Spinal Cord Stimulator System, 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 177-day FDA review.

K160600 · Stimwave Technologies Incorporated · Neurology device
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Aug 2016
Decision
177d
Days
Class 2
Risk

K160600 is an FDA 510(k) clearance for the Freedom Spinal Cord Stimulator System. 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 August 26, 2016 after a review of 177 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 - K160600

510(k) Number K160600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2016
Decision Date August 26, 2016
Days to Decision 177 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
29d slower than avg
Panel avg: 148d · This submission: 177d
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 K160600.
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
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
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · Stimwave Technologies Incorporated · Oct 2014