Intracept Intraosseous Nerve Ablation System

Probe, Radiofrequency Lesion

Relievant Medsystems, Inc.

The following data is part of a premarket notification filed by Relievant Medsystems, Inc. with the FDA for Intracept Intraosseous Nerve Ablation System.

Pre-market Notification Details

Device IDK222281
510k NumberK222281
Device Name:Intracept Intraosseous Nerve Ablation System
ClassificationProbe, Radiofrequency Lesion
Applicant Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale,  CA  94085
ContactThomas A. Slater
CorrespondentThomas A. Slater
Relievant Medsystems, Inc. 1230 Midas Way, Suite 200 Sunnyvale,  CA  94085
Product CodeGXI  
CFR Regulation Number882.4725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-29
Decision Date2022-10-26

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