AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX— 510(k) K010008
Substantially EquivalentMicronet Medical, Inc.
FDA 510(k) clearance K010008 for AXXESS SPINAL CORD STIMULATION LEAD, MODEL 8000 SERIES, INCLUDING 80XX, 81XX, AND 82XX, Substantially Equivalent on 2001-07-16. Applicant: Micronet Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Micronet Medical, Inc.
- 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
- White Bear Lake,, MN, 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
Adverse 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.