Clearance Summary
UroLift System (UL400) received FDA 510(k) clearance under submission number K193269, sponsored by Neotract, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2019-12-20.
- Submission: K193269
- Applicant / Sponsor: Neotract, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5530
- Decision date: 2019-12-20
Classification & Regulation
This clearance is catalogued under FDA product code PEW and 21 CFR 876.5530, within the Gastroenterology, Urology review panel as a Class II device.