Clearance Summary
TubeClear Control Box and Clearing Stem received FDA 510(k) clearance under submission number K163092, sponsored by Actuated Medical, Inc.. 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 2016-11-30.
- Submission: K163092
- Applicant / Sponsor: Actuated Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5980
- Decision date: 2016-11-30
Classification & Regulation
This clearance is catalogued under FDA product code KNT and 21 CFR 876.5980, within the Gastroenterology, Urology review panel as a Class II device.