Cleared Traditional

K172644 - Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base

K172644 is an FDA 510(k) clearance for Sandshark Injectable Anchor 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 63-day FDA review.

K172644 · Stimwave Technologies Incorporated · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2017
Decision
63d
Days
Class 2
Risk

K172644 is an FDA 510(k) clearance for the Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Ancho.... 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 November 3, 2017 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stimwave Technologies Incorporated devices

FDA 510(k) Submission Details - K172644

510(k) Number K172644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2017
Decision Date November 03, 2017
Days to Decision 63 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
85d faster than avg
Panel avg: 148d · This submission: 63d
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 K172644.
Freedom Spinal Cord Stimulator (SCS) System
K182720 · Stimwave Technologies Incorporated · Mar 2019
Nalu Neurostimulation System
K183047 · Boston Scientific Neuromodulation · Mar 2019
Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit
K180981 · Stimwave Technologies Incorporated · Sep 2018
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
Freedom Spinal Cord Stimulator System
K160600 · Stimwave Technologies Incorporated · Aug 2016