Vesta RF Cannula— 510(k) K190259

Name: FDA 510(k) clearance K190259
Creator: U.S. Food and Drug Administration
Published: 2020-02-07

Substantially Equivalent

Biomerics

FDA 510(k) clearance K190259 for Vesta RF Cannula, Substantially Equivalent on 2020-02-07. Applicant: Biomerics. Device class: 2.

Clearance details

Applicant: Biomerics
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2019-02-07
Decision date: 2020-02-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Salt Lake City, UT, US

Download summary PDF View on FDA.gov ↗

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K251243 — OneRF Trigeminal Nerve Radiofrequency Probes2025-08-15
K242841 — Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20)2025-05-27
K250213 — OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) +1 more2025-05-15

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K121773 — NIMBUS ELECTROSURGICAL RADIOFREQUENCY MULTITINED EXPANDABLE ELECTRODE2012-09-21

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.