Clearance Summary
CONTINUOUS FLOW Y-TUBING received FDA 510(k) clearance under submission number K010122, sponsored by G.U.-Tek. 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 2001-06-04.
- Submission: K010122
- Applicant / Sponsor: G.U.-Tek
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5130
- Decision date: 2001-06-04
Classification & Regulation
This clearance is catalogued under FDA product code LJH and 21 CFR 876.5130, within the Gastroenterology, Urology review panel as a Class II device.