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 Neurosurgical Laser With Mr Thermography
510(k) Number K211269
Device Name Visualase MRI-Guided Laser Ablation System (SW 3.4)
Applicant
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Applicant Contact Sharon McDermott
Correspondent
Medtronic Navigation, Inc.
826 Coal Creek Cir.
Louisville,  CO  80027
Correspondent Contact Sharon McDermott
Regulation Number878.4810
Classification Product Code
ONO  
Subsequent Product Code
GEX  
Date Received04/27/2021
Decision Date 01/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-