Clearance Summary
Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 received FDA 510(k) clearance under submission number K193542, sponsored by Bellco Srl. 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 2020-10-08.
- Submission: K193542
- Applicant / Sponsor: Bellco Srl
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5860
- Decision date: 2020-10-08
Classification & Regulation
This clearance is catalogued under FDA product code KDI and 21 CFR 876.5860, within the Gastroenterology, Urology review panel as a Class II device.