BAXANO NEURO CHECK DEVICE— 510(k) K092729

Substantially Equivalent

Baxano, Inc.

FDA 510(k) clearance K092729 for BAXANO NEURO CHECK DEVICE, Substantially Equivalent on 2009-10-02. Applicant: Baxano, Inc..

Clearance details

Applicant: Baxano, Inc.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 2009-09-04
Decision date: 2009-10-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Hillsborough, 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.