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

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172644

by Stimwave Technologies Incorporated

Identifiers

510(k) Number
K172644 FDA 510(k)
FDA Product Code
GZB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5880 FDA 510(k)
Regulation Number
882.5880 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base is a sterile, single-use accessory designed to fixate the Stimwave Freedom Stimulator to patient tissue. It consists of a carbothane anchor, an ABS/stainless steel deployment handle (Injectroducer), a loading rod, and a loading base.

It is used in hospitals or ambulatory surgical centers by orthopedic surgeons, neurosurgeons, or other qualified physicians. The device is supplied sterile and intended for single-use only. It has received FDA 510(k) clearance under product code GZB and regulation number 882.5880, with a decision of substantially equivalent based on traditional review.

Frequently asked questions

What is the Sandshark Injectable Anchor Kit used for?

It is used to fixate the Stimwave Freedom Stimulator to patient tissue during implantation procedures. The kit provides the components needed to deploy and secure the stimulator anchor in place, ensuring stable fixation for spinal cord stimulation therapy.

Is the Sandshark Injectable Anchor Kit sterile and single-use?

Yes, the device is supplied sterile and intended for single-use only. This ensures infection control and eliminates the need for reprocessing, making it suitable for use in hospitals and ambulatory surgical centers by qualified physicians.

What components are included in the Sandshark Injectable Anchor Kit?

The kit includes a carbothane anchor, an ABS/stainless steel deployment handle (Injectroducer), a loading rod with anchor, and a loading base. These components work together to enable the delivery and fixation of the Stimwave Freedom Stimulator to tissue.

What regulatory pathway was used for the Sandshark Injectable Anchor Kit?

The device received FDA 510(k) clearance under product code GZB and regulation number 882.5880. The clearance was based on a traditional review and determined to be substantially equivalent to a predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with ..., Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod With ..., Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stimwave Technologies Incorporated

Sources (1)

  • FDA 510(k) K172644 24 fields · synced Sep 24, 2026