Cleared Traditional

Intracept Intraosseous Nerve Ablation System

K213836 · Relievant Medsystems, Inc. · Neurology
Mar 2022
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K213836 is an FDA 510(k) clearance for the Intracept Intraosseous Nerve Ablation System, a Probe, Radiofrequency Lesion (Class II — Special Controls, product code GXI), submitted by Relievant Medsystems, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 11, 2022, 92 days after receiving the submission on December 9, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K213836 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2021
Decision Date March 11, 2022
Days to Decision 92 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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