OCTRODEX(TM), QUATTRODEX(TM), INTRODEX(TM), EPIDURAL NEEDLE, STYLETS— 510(k) K112214
Substantially EquivalentSt. 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. Device class: 2.
Clearance details
- Applicant
- St. Jude Medical Neuromodulation
- Product code
- Code GZB
- Device class
- Class 2
- Regulation
- 21 CFR 882.5880
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Plano, TX, US
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- K201618 — Nalu Neurostimulation SCS system
More clearances from St. Jude Medical Neuromodulation
view allAdverse events under product code GZB
product code GZB- Death
- 4
- Injury
- 1,879
- Other
- 2
- Total
- 1,885
Source: openFDA MAUDE database, through . 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.