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

- Pathway: 510(k) (Traditional)
- Applicant: Stimwave Technologies Incorporated
- Decided: Nov 3, 2017 after 63 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: 10 generations back to K930738 (1994). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113805: Fixate Tissue Band, Anulex Technologies, Inc. (2012) Summary page 4.
- K150924: 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, Anchor Innovation Medical (A.I.M.) (2015) Summary page 4.

## Most influential descendants
- K191466: SandShark Injectable Anchor (SIA) System (2019), 0 descendants of its own

## 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/K172644
Methodology: https://510kreport.com/methodology