# K111985: Myoguide System Model 8008

- Pathway: 510(k) (Traditional)
- Applicant: Intronix Technologies Corp.
- Decided: Dec 30, 2011 after 171 days
- Product code: BXN (Stimulator, Nerve, Battery-Powered)
- Device class: 2
- Regulation: 21 CFR 868.2775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K882438 (1988). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062478: Clavis, Medtronic A/S (2007) Summary page 1.
- K102084: Stimpod NMS450 Nerve Stimulator, Xavant Technology (Pty), Ltd. (2010) Summary page 1.

## Indications for use
The Intronix Model 8008 Myoguide System (Myoguide) is a medical device intended as a stimulator for nerve localization as well as an aid for guidance of injections into the muscles.

Source page: https://510kreport.com/device/K111985
Methodology: https://510kreport.com/methodology