Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)— 510(k) K180369
Substantially EquivalentRelievant Medsystems
FDA 510(k) clearance K180369 for Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe), Substantially Equivalent on 2018-09-14. Applicant: Relievant Medsystems. Device class: 2.
Clearance details
- Applicant
- Relievant Medsystems
- Product code
- Code GXI
- Device class
- Class 2
- Regulation
- 21 CFR 882.4725
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sunnyvale, CA, US
Recent devices under product code GXI
view allMore clearances from Relievant Medsystems
view all- K190504 — Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
- K171143 — Relievant Medsystems RF Generator
- K170827 — INTRACEPT Intraosseous Nerve Ablation System
- K153272 — INTRACEPT Flexible Bi-Polar RF Probe and Easy Access Instrument Set
- K100641 — INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)
Adverse events under product code GXI
product code GXI- Death
- 3
- Injury
- 171
- Total
- 174
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.