Cleared Traditional

RF INTRODUCTION CANNULA

K041021 · Epimed International, Inc. · Neurology
Sep 2004
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K041021 is an FDA 510(k) clearance for the RF INTRODUCTION CANNULA, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Epimed International, Inc. (Johnstown, US). The FDA issued a Cleared decision on September 16, 2004, 149 days after receiving the submission on April 20, 2004. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K041021 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2004
Decision Date September 16, 2004
Days to Decision 149 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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