# K110696: Neuro Check Device with IO-Flex Wire

- Pathway: 510(k) (Traditional)
- Applicant: Baxano, Inc.
- Decided: Jul 7, 2011 after 115 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: 6 generations back to K842956 (1984). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092729: Baxano Neuro Check Device, Baxano, Inc. (2009) Summary page 1.
- K062765: Modification to Nuvasive Neurovision JJB System, Nuvasive, Inc. (2007) Summary page 1.
- K061113: Orthomon, Axon Systems, Inc. (2006) Summary page 1.
- K924723: Cadwell Sierra, Cadwell Laboratories, Inc. (1993) Summary page 1.
- K100958: Modification to: Microblade Shaver and Accessories, Baxano, Inc. (2010) Summary page 2.

## Indications for use
The Baxano Neuro CheckTM Device is intended for use with an iO-Flex cutting and biting device for location of motor nerves in settings where visualization is compromised.

Source page: https://510kreport.com/device/K110696
Methodology: https://510kreport.com/methodology