Cleared Traditional

K160600 - Freedom Spinal Cord Stimulator System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160600 · Stimwave Technologies Incorporated · Neurology device
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.

Submission Details

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
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 162d · This submission: 177d
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.