Clearance Summary
Colonplus Colonkit small, Colonplus Colonkit large, Colonplus Colonkit with Stop Collar 6, Colonplus Colonkit with Stop Collar 10 received FDA 510(k) clearance under submission number K152834, sponsored by Colonplus Equipments & Speculums, S.L.. 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 2016-08-10.
- Submission: K152834
- Applicant / Sponsor: Colonplus Equipments & Speculums, S.L.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5220
- Decision date: 2016-08-10
Classification & Regulation
This clearance is catalogued under FDA product code KPL and 21 CFR 876.5220, within the Gastroenterology, Urology review panel as a Class II device.