INTRACEPT Intraosseous Nerve Ablation System— 510(k) K170827

Substantially Equivalent

Relievant Medsystems

FDA 510(k) clearance K170827 for INTRACEPT Intraosseous Nerve Ablation System, Substantially Equivalent on 2017-08-09. Applicant: Relievant Medsystems.

Clearance details

Applicant: Relievant Medsystems
Product code: Code GXI
Advisory panel: Neurology
Date received: 2017-03-20
Decision date: 2017-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Redwood City, CA, US

Download summary PDF View on FDA.gov ↗

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.