Clearance Summary
Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter)) received FDA 510(k) clearance under submission number K243052, sponsored by Bright Uro, 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 2025-03-24.
- Submission: K243052
- Applicant / Sponsor: Bright Uro, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1620
- Decision date: 2025-03-24
Classification & Regulation
This clearance is catalogued under FDA product code EXQ and 21 CFR 876.1620, within the Gastroenterology, Urology review panel as a Class II device.