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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 K170827
Device Name INTRACEPT Intraosseous Nerve Ablation System
Applicant
Relievant Medsystems
2688 Middlefield Rd., Suite A
Redwood City,  CA  94063
Applicant Contact Alex DiNello
Correspondent
Relievant Medsystems
2688 Middlefield Rd., Suite A
Redwood City,  CA  94063
Correspondent Contact Laurie Hook
Regulation Number882.4725
Classification Product Code
GXI  
Date Received03/20/2017
Decision Date 08/09/2017
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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