# K100958: Modification to: Microblade Shaver and Accessories

- Pathway: 510(k) (Special)
- Applicant: Baxano, Inc.
- Decided: Jul 23, 2010 after 107 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: 1 generation back to K063231 (2007). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 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.

## Most influential descendants
- K113533: Neuro Check Device with IO-Flex Wire (2012), 0 descendants of its own
- K110696: Neuro Check Device with IO-Flex Wire (2011), 0 descendants of its own

## Indications for use
The Baxano, Inc. MicroBladeShaver 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/K100958
Methodology: https://510kreport.com/methodology