Clearance Summary
RECTOSIGHT RS 300-04 received FDA 510(k) clearance under submission number K994130, sponsored by Sightline Technologies , Ltd.. 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 2000-06-30.
- Submission: K994130
- Applicant / Sponsor: Sightline Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2000-06-30
Classification & Regulation
This clearance is catalogued under FDA product code FER and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.