Intracept Intraosseous Nerve Ablation System— 510(k) K213836

Substantially Equivalent

Relievant Medsystems, Inc.

FDA 510(k) clearance K213836 for Intracept Intraosseous Nerve Ablation System, Substantially Equivalent on 2022-03-11. Applicant: Relievant Medsystems, Inc..

Clearance details

Applicant: Relievant Medsystems, Inc.
Product code: Code GXI
Advisory panel: Neurology
Date received: 2021-12-09
Decision date: 2022-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, 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.