Clearance Summary
COLONOSIGHT MODEL 510B received FDA 510(k) clearance under submission number K032688, 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 2004-03-05.
- Submission: K032688
- Applicant / Sponsor: Sightline Technologies , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2004-03-05
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.