Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)— 510(k) K180369

Substantially Equivalent

Relievant 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.

Clearance details

Applicant: Relievant Medsystems
Product code: Code GXI
Advisory panel: Neurology
Date received: 2018-02-12
Decision date: 2018-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

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Adverse events under product code GXI

product code GXI

Death: 3
Injury: 171
Total: 174

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.