# K063231: Microblade Shaver and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Baxano, Inc.
- Decided: Apr 16, 2007 after 173 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Codman Laminectomy Shaver: named in the summary without a submission number
- (no number) Integra Ruggles Instrument: named in the summary without a submission number
- (no number) Zeppelin Laminectomy Rongeur: named in the summary without a submission number
- (no number) Ellman Disc FX System (accessories): named in the summary without a submission number

## Most influential descendants
- K100958: Modification to: Microblade Shaver and Accessories (2010), 2 descendants of its own
- 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. 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/K063231
Methodology: https://510kreport.com/methodology