# K032034: Ans Axxess Percutaneous Lead

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Oct 3, 2003 after 94 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
The ANS AxxessTMPercutaneous Leads (41XX Series) are designed to be utilized as the lead component of spinal cord stimulation systems and is used to aid in the management of chronic pain of the trunk and/or extremities. The ANS AxxessTMPercutaneous Lead system is designed to be used with the following devices: ANS Renew Receiver (34XX series) and Transmitter (35XX series) ANS Lead Extension Models 3341, 3342, 3343, and 3346

Source page: https://510kreport.com/device/K032034
Methodology: https://510kreport.com/methodology