510(k) K010008— AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX

Substantially Equivalent

Micronet Medical, Inc.

Clearance details

Applicant: Micronet Medical, Inc.
Product code: Code GZB
Advisory panel: Neurology
Date received: 2001-01-02
Decision date: 2001-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Bear Lake,, MN, US

Adverse events under product code GZB

product code GZB

Death: 4
Injury: 1,879
Other: 2
Total: 1,885

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.