Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Probe, Radiofrequency Lesion
510(k) Number K213836
FOIA Releasable 510(k) 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
Predetermined Change
Control Plan Authorized		 No
-
-