RemOVE System

Endoscopic Electrosurgical Clip Cutting System

The following data is part of a De Novo classification by Ovesco Endoscopy Ag with the FDA for Remove System.

DeNovo ID	DEN160014
Device Name:	RemOVE System
Classification	Endoscopic Electrosurgical Clip Cutting System
Applicant	OVESCO ENDOSCOPY AG dorfackerstrasse 26 Tuebingen,, DE 72074
Contact	Med.marc O. Schurr
Product Code	QAG
CFR Regulation Number	876.4310 [🔎]
Decision	Granted (DENG)
510(k) Premarket Notification	Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory Board	Gastroenterology/Urology
Classification Advisory	Obstetrics/Gynecology
Type	Direct
Date Received	2016-04-11
Decision Date	2017-12-22
FDA Review	Decision Summary
Reclassification Order:	Reclassification Order