# 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

- Pathway: 510(k) (Traditional)
- Applicant: Anchor Innovation Medical (A.I.M.)
- Decided: Jul 27, 2015 after 112 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: 9 generations back to K930738 (1994). 13 ancestors in all.
2 later devices descend 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.

## Most influential descendants
- K172644: Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (2017), 1 descendant of its own
- K191466: SandShark Injectable Anchor (SIA) System (2019), 0 descendants of its own

## Indications for use
The A.I.M. Lead Loop Suturing Device is intended for use in securing Spinal Cord Stimulation (SCS) leads and catheters to the fascia or intra-spinous/supra-spinous ligament.

Source page: https://510kreport.com/device/K150924
Methodology: https://510kreport.com/methodology