MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS— 510(k) K123299
Substantially EquivalentSt. Jude Medical Neuromodulation
FDA 510(k) clearance K123299 for MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS, Substantially Equivalent on 2013-01-18. 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
Recent devices under product code GZB
view all- K233801 — Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation
- K221376 — Nalu Neurostimulation System
- K203547 — Nalu Neurostimulation System
- K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits
- 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 →
Recalls naming K123299
K-number listed on FDA's recall record- Z-2718-2014 — Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
- Z-2719-2014 — Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123299.
Data sourced from openFDA. This site is unofficial and independent of the FDA.