Clearance Summary
UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge received FDA 510(k) clearance under submission number K201837, 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 2020-07-31.
- Submission: K201837
- Applicant / Sponsor: Neotract, Inc.
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5530
- Decision date: 2020-07-31
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.