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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 table mounted miniaturized electromechanical surgical system
De Novo Number DEN230025
Device Name MIRA Surgical System
Requester
virtual incision
2125 transformation drive, suite 1300
lincoln,  NE  68508
Contact florence beck
Regulation Number878.4962
Classification Product Code
SAB  
Date Received04/11/2023
Decision Date 02/23/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
-
-