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 Powered Laser Surgical Instrument
510(k) Number K231061
Device Name NeuroBlate System
Applicant
Monteris Medical
131 Cheshire Lane
Suite 100
Minnetonka,  MN  55305
Applicant Contact David H Mueller
Correspondent
Monteris Medical
131 Cheshire Lane
Suite 100
Minnetonka,  MN  55305
Correspondent Contact David H Mueller
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
HAW   ONO  
Date Received04/13/2023
Decision Date 12/08/2023
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
-
-