# K083242: Neurosign Avalanche Motor Nerve Monitor

- Pathway: 510(k) (Traditional)
- Applicant: The Magstim Company, Ltd.
- Decided: Jul 29, 2009 after 268 days
- Product code: ETN (Stimulator, Nerve)
- Device class: 2
- Regulation: 21 CFR 874.1820
- 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 K923056 (1992). 3 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991583: Neurosign 400, 4 Channel Motor Nerve Monitor, The Magstim Company, Ltd. (1999) Summary page 2.

## Most influential descendants
- K111647: C2 Nervemonitor System with Accessories (2011), 2 descendants of its own
- K152505: C2 NerveMonitor System (2016), 1 descendant of its own
- K233001: Bioscope Neuromonitor Device (2024), 0 descendants of its own
- K223254: C2 Xplore (2023), 0 descendants of its own

## Indications for use
The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery. The intended uses of the Neurosign Avalanche Motor Nerve Monitor is: 2 channel thyroidectomy and parathyroidectomy, mastoidectomy 4 channel parotidectomy, mastoidectomy, skull-base

Source page: https://510kreport.com/device/K083242
Methodology: https://510kreport.com/methodology