Cleared Traditional

Racz Neurostat RF Generator

K232632 · Epimed International · Neurology
May 2024
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K232632 is an FDA 510(k) clearance for the Racz Neurostat RF Generator, a Generator, Lesion, Radiofrequency (Class II — Special Controls, product code GXD), submitted by Epimed International (Johnstown, US). The FDA issued a Cleared decision on May 24, 2024, 268 days after receiving the submission on August 30, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4400.

Submission Details

510(k) Number K232632 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2023
Decision Date May 24, 2024
Days to Decision 268 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXD — Generator, Lesion, Radiofrequency
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4400

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