# K053250: Ans 90 CM and 110 CM (3100 and 3200 Series) Lead Kit

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Dec 15, 2005 after 24 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
Advanced Neuromodulation Systems 90 cm and 110 cm (3100 and 3200 Series) Lead Kits are indicated for 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 and are intended to be used with Advanced Neuromodulation Systems receivers, IPGs, transmitters, and/or antennae.

Source page: https://510kreport.com/device/K053250
Methodology: https://510kreport.com/methodology