Clearance Summary
remOVE System received FDA 510(k) clearance under submission number DEN160014, sponsored by Ovesco Endoscopy AG. The device was reviewed via the Direct premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2017-12-22.
- Submission: DEN160014
- Applicant / Sponsor: Ovesco Endoscopy AG
- Clearance pathway: Direct
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 876.4310
- Decision date: 2017-12-22
Classification & Regulation
This clearance is catalogued under FDA product code QAG and 21 CFR 876.4310, within the Obstetrics/Gynecology review panel as a Class II device.