BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25— 510(k) K081742

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K081742 for BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25, Substantially Equivalent on 2008-09-17. Applicant: Baxano, Inc..

Clearance details

Applicant: Baxano, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2008-06-19
Decision date: 2008-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.