OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more— 510(k) K250213

Name: FDA 510(k) clearance K250213
Creator: U.S. Food and Drug Administration
Published: 2025-05-15

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K250213 for OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more, Substantially Equivalent on 2025-05-15. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Device name as filed: OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)
Applicant: Stryker Instruments
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2025-01-24
Decision date: 2025-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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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.