INTRACEPT Intraosseous Nerve Ablation System— 510(k) K170827
Substantially EquivalentRelievant Medsystems
FDA 510(k) clearance K170827 for INTRACEPT Intraosseous Nerve Ablation System, Substantially Equivalent on 2017-08-09. 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
- Redwood City, 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
- K180369 — Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)
- K171143 — Relievant Medsystems RF Generator
- 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.