Cleared Traditional

Intracept Intraosseous Nerve Ablation System

K222281 · Relievant Medsystems, Inc. · Neurology
Oct 2022
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K222281 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 October 26, 2022, 89 days after receiving the submission on July 29, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4725.

Submission Details

510(k) Number K222281 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2022
Decision Date October 26, 2022
Days to Decision 89 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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