# K080494: Baxano Ultra Low Profile Rongeur

- Pathway: 510(k) (Special)
- Applicant: Baxano, Inc.
- Decided: Mar 4, 2008 after 11 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.
5 later devices descend from it; 3 cite it directly.
0 of 6 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) Baxano Ultra Low Profile (ULP) Rongeur: named in the summary without a submission number

## Most influential descendants
- K100958: Modification to: Microblade Shaver and Accessories (2010), 2 descendants of its own
- K081742: Baxano Neural Localization Probe 1.75 and 1.25 (2008), 2 descendants of its own
- K092729: Baxano Neuro Check Device (2009), 1 descendant 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. Ultra Low Profile Rongeur is designed for accessing, cutting, and biting soft tissue and bone during surgery involving the spinal column.

Source page: https://510kreport.com/device/K080494
Methodology: https://510kreport.com/methodology