Cleared Traditional

K172644 - Sandshark Injectable Anchor Kit

K172644 is the FDA 510(k) clearance for Sandshark Injectable Anchor Kit by Stimwave Technologies Incorporated. It is a Class 2 Neurology device (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

Submission Details

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
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.

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.

Regulatory Peers - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 75
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
SWIFT-LOCK ANCHOR
K140272 · St Jude Medical · May 2014
MULTI LEAD TRIAL CABLE
K130545 · St Jude Medical · Jun 2013
RAPID PROGRAMMER
K113611 · St Jude Medical · Apr 2012