# K991784: Renew Lead Extension

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Jun 24, 1999 after 30 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: 2 generations back to K810182 (1981). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960728: One Step Connect Leads (Quattrode, Octrode, Cervitrode), Neuromed, Inc. (1996) Summary page 2.
- K930536: Neuromed Octrode Model MNR-88A-B-C Neurostim Rec, Neuromed, Inc. (1994) Summary page 2.

## Most influential descendants
- K992946: Renew Receiver (1999), 0 descendants of its own

## Indications for use
ANS Lead Extensions are indicated for the treatment 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. Lead extensions are intended to be used with Advanced Neuromodulation Systems’, leads, receivers, transmitters, and antennae.

Source page: https://510kreport.com/device/K991784
Methodology: https://510kreport.com/methodology