# K113533: Neuro Check Device with IO-Flex Wire

- Pathway: 510(k) (Special)
- Applicant: Baxano, Inc.
- Decided: Apr 11, 2012 after 133 days
- Product code: HAE (Rongeur, Manual)
- Device class: 2
- Regulation: 21 CFR 882.4840
- 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 K063231 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063231: Microblade Shaver and Accessories, Baxano, Inc. (2007) Summary page 1.
- K080494: Baxano Ultra Low Profile Rongeur, Baxano, Inc. (2008) Summary page 1.
- K100958: Modification to: Microblade Shaver and Accessories, Baxano, Inc. (2010) Summary page 4.

## Cited in the summary but kept off the family tree
- K110958: Versajet II Hydrosurgery System Console / Exact Handpieces / Plus Handpieces, Versajet Footswitch, Smith & Nephew, Inc. (2011). Our reading of the summary gave K110958, FDA’s number for Versajet II Hydrosurgery System Console / Exact Handpieces… (Smith & Nephew, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Baxano MicroBlade Shaver Device and Accessories”. Kept off the family tree.

## Indications for use
The Baxano Inc. MicroBlade Shaver and Accessories are designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

Source page: https://510kreport.com/device/K113533
Methodology: https://510kreport.com/methodology