# K081208: Cinch Anchor, Model 1194

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Jul 18, 2008 after 80 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The CinchTM anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Source page: https://510kreport.com/device/K081208
Methodology: https://510kreport.com/methodology