Clearance Summary
RECTOSIGHT RS300-04;AND PROTOSIGHT PS300-04 DEVICE received FDA 510(k) clearance under submission number K011825, sponsored by Sightline Technologies , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2001-07-11.
- Submission: K011825
- Applicant / Sponsor: Sightline Technologies , Ltd.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2001-07-11
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.