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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 K190504
Device Name Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator
Applicant
Relievant Medsystems
358 Moffett Park Dr., Suite 105
Sunnyvale,  CA  94089
Applicant Contact Alex DiNello
Correspondent
Relievant Medsystems
358 Moffett Park Dr., Suite 105
Sunnyvale,  CA  94089
Correspondent Contact Laurie Hook
Regulation Number882.4725
Classification Product Code
GXI  
Subsequent Product Code
GXD  
Date Received03/01/2019
Decision Date 05/03/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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