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 Marker, Radiographic, Implantable
510(k) Number K183400
Device Name EnVisio Navigation Sytem
Applicant
Elucent Medical, Inc.
7480 Flying Cloud Dr., Suite 110
Eden Prairie,  MN  55344
Applicant Contact Debra Kridner
Correspondent
Elucent Medical, Inc.
7480 Flying Cloud Dr., Suite 110
Eden Prairie,  MN  55344
Correspondent Contact Debra Kridner
Regulation Number878.4300
Classification Product Code
NEU  
Date Received12/07/2018
Decision Date 03/22/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-