# K992946: Renew Receiver

- Pathway: 510(k) (Special)
- Applicant: Advanced Neuromodulation Systems
- Decided: Sep 24, 1999 after 23 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: 3 generations back to K810182 (1981). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930536: Neuromed Octrode Model MNR-88A-B-C Neurostim Rec, Neuromed, Inc. (1994) Summary page 2.
- K991784: Renew Lead Extension, Advanced Neuromodulation Systems (1999) Summary page 2.

## Indications for use
ANS Renew Receivers 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. Receivers are intended to be used with Advanced Neuromodulation System’, leads, extensions, transmitters and antennae.

Source page: https://510kreport.com/device/K992946
Methodology: https://510kreport.com/methodology
