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 endoscopic electrosurgical clip cutting system
De Novo Number DEN160014
Device Name remOVE System
Requester
OVESCO ENDOSCOPY AG
dorfackerstrasse 26
tuebingen,,  DE 72074
Contact med.marc o. schurr
Regulation Number876.4310
Classification Product Code
QAG  
Date Received04/11/2016
Decision Date 12/22/2017
Decision granted (DENG)
Classification Advisory Committee Obstetrics/Gynecology
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-