ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT— 510(k) K053250
Substantially EquivalentAdvanced Neuromodulation Systems
FDA 510(k) clearance K053250 for ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT, Substantially Equivalent on 2005-12-15. Applicant: Advanced Neuromodulation Systems. Device class: 2.
Clearance details
- Applicant
- Advanced Neuromodulation Systems
- 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
- Special
- 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 Advanced Neuromodulation Systems
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.