# K191466: SandShark Injectable Anchor (SIA) System

- Pathway: 510(k) (Traditional)
- Applicant: Stimwave Technologies, Inc.
- Decided: Nov 7, 2019 after 157 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K930738 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172644: Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base, Stimwave Technologies Incorporated (2017) Summary page 4.

## Indications for use
The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the stimulator to the fascia or interspinous/supra- spinous ligament.

Source page: https://510kreport.com/device/K191466
Methodology: https://510kreport.com/methodology