Cleared Traditional

K141399 - FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM

K141399 is an FDA 510(k) clearance for FREEDOM SPINAL CORD STIMULATOR (SCS) 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 135-day FDA review.

K141399 · Stimwave Technologies Incorporated · Neurology device
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Oct 2014
Decision
135d
Days
Class 2
Risk

K141399 is an FDA 510(k) clearance for the FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Stimwave Technologies Incorporated (Miami Beach, US). The FDA issued a Cleared decision on October 10, 2014 after a review of 135 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 - K141399

510(k) Number K141399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2014
Decision Date October 10, 2014
Days to Decision 135 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
13d faster than avg
Panel avg: 148d · This submission: 135d
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 K141399.
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
SWIFT-LOCK ANCHOR
K140272 · St Jude Medical · May 2014
MULTI LEAD TRIAL CABLE
K130545 · St Jude Medical · Jun 2013
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
K123299 · St. Jude Medical Neuromodulation · Jan 2013