OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS— 510(k) K112214

Substantially Equivalent

St. Jude Medical Neuromodulation

FDA 510(k) clearance K112214 for OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS, Substantially Equivalent on 2011-11-17. Applicant: St. Jude Medical Neuromodulation.

Clearance details

Applicant: St. Jude Medical Neuromodulation
Product code: Code GZB
Advisory panel: Neurology
Date received: 2011-08-02
Decision date: 2011-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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.