510(k) DEN160014
- Device
- remOVE System
- Applicant
- Ovesco Endoscopy AG
- 510(k) number
- DEN160014
- Product code
- QAG
- Decision
- Unknown (DENG)
- Decision date
- 2017-12-22
- Date received
- 2016-04-11
- Regulation
- 876.4310
- Classification name
- Endoscopic Electrosurgical Clip Cutting System
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Obstetrics/Gynecology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Med.Marc O. Schurr
- Address
- Dorfackerstrasse 26 Tuebingen DE 72074 72074
FDA Registration Numbers#
- 3008720584
- 3009217531
- 3006696607
Source Documents#
510(k) summary PDF not indicated by FDA