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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K213836
Device Name Intracept Intraosseous Nerve Ablation System
Applicant
Relievant Medsystems, Inc.
1230 Midas Way, Suite 200
Sunnyvale,  CA  94085
Applicant Contact Thomas A Slater
Correspondent
Relievant Medsystems, Inc.
1230 Midas Way, Suite 200
Sunnyvale,  CA  94085
Correspondent Contact Thomas A Slater
Regulation Number882.4725
Classification Product Code
GXI  
Date Received12/09/2021
Decision Date 03/11/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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