Clearance Summary
invendoscopy E210 System received FDA 510(k) clearance under submission number K173085, sponsored by Invendo Medical GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2018-01-08.
- Submission: K173085
- Applicant / Sponsor: Invendo Medical GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2018-01-08
Classification & Regulation
This clearance is catalogued under FDA product code FDF and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.