# Baxano, Inc.

- Location (FDA's records): San Jose, CA
- FDA decisions: 10 (2007–2012): 10 510(k) clearances
- Product codes: HAE (6), ETN (3), BSO (1)
- Predicates its devices cite: 18 (9 its own); citations of its devices by later devices: 11 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Nuvasive, Inc.: 2 (https://510kreport.com/company/nuvasive)
- I-Flow Corp.: 1 (https://510kreport.com/company/i-flow)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)
- Axiom Medical, Inc.: 1 (https://510kreport.com/company/axiom-medical)
- Medtronic Xomed, Inc.: 1 (https://510kreport.com/company/medtronic-xomed)
- Wr Medical Electronics Co.: 1 (https://510kreport.com/company/wr-medical-electronics)
- Axon Systems, Inc.: 1 (https://510kreport.com/company/axon-systems)
- Cadwell Laboratories, Inc.: 1 (https://510kreport.com/company/cadwell-laboratories)

## Firms that cite its devices most
- X-Sten Corp.: 1 (https://510kreport.com/company/x-sten)
- Instrumed International, Inc.: 1 (https://510kreport.com/company/instrumed-international)

## Its most-cited devices
- K080494: Baxano Ultra Low Profile Rongeur (2008), cited by 3
- K100958: Modification to: Microblade Shaver and Accessories (2010), cited by 2
- K063231: Microblade Shaver and Accessories (2007), cited by 2
- K062711: Ultra Low Profile Rongeur (2007), cited by 2
- K081742: Baxano Neural Localization Probe 1.75 and 1.25 (2008), cited by 1
- K092729: Baxano Neuro Check Device (2009), cited by 1

## Recent decisions
- K113073: IO-Tome Device (Jul 27, 2012)
- K113533: Neuro Check Device with IO-Flex Wire (Apr 11, 2012)
- K110696: Neuro Check Device with IO-Flex Wire (Jul 7, 2011)
- K102594: IO-Flex Catheter (Jan 19, 2011)
- K100958: Modification to: Microblade Shaver and Accessories (Jul 23, 2010)
- K092729: Baxano Neuro Check Device (Oct 2, 2009)
- K081742: Baxano Neural Localization Probe 1.75 and 1.25 (Sep 17, 2008)
- K080494: Baxano Ultra Low Profile Rongeur (Mar 4, 2008)

Source page: https://510kreport.com/company/baxano