Clearance Summary
TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU)) received FDA 510(k) clearance under submission number K201617, sponsored by Schoelly Fiberoptic GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2021-03-12.
- Submission: K201617
- Applicant / Sponsor: Schoelly Fiberoptic GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 2021-03-12
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.