Cleared Traditional

Rulo Radiofrequency Lesion Probe

K190256 · Epimed International, Inc. · Neurology
Mar 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K190256 is an FDA 510(k) clearance for the Rulo Radiofrequency Lesion Probe, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Epimed International, Inc. (Farmers Branch, US). The FDA issued a Cleared decision on March 8, 2019, 29 days after receiving the submission on February 7, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K190256 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 2019
Decision Date March 08, 2019
Days to Decision 29 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXI — Probe, Radiofrequency Lesion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4725

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