Rulo Radiofrequency Lesion Probe— 510(k) K190256

Name: FDA 510(k) clearance K190256
Creator: U.S. Food and Drug Administration
Published: 2019-03-08

Substantially Equivalent

Epimed International, Inc.

FDA 510(k) clearance K190256 for Rulo Radiofrequency Lesion Probe, Substantially Equivalent on 2019-03-08. Applicant: Epimed International, Inc.. Device class: 2.

Clearance details

Applicant: Epimed International, Inc.
Product code: Code GXI
Device class: Class 2
Regulation: 21 CFR 882.4725
Advisory panel: Neurology
Date received: 2019-02-07
Decision date: 2019-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Farmers Branch, TX, 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.