510(k) K253537

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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A) by Bright Uro, Inc. — Product Code EXQ

K253537 is an FDA 510(k) premarket notification submitted by Bright Uro, Inc. for the device "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)); Glean Urodynamics System Abdominal Sensor (GUS-1000-A)". The FDA issued a decision of Substantially Equivalent on April 16, 2026. The device falls under product code EXQ (Cystometer, Electrical Recording), a Class II device regulated under 21 CFR 876.1620. Bright Uro, Inc. has at least 1 other 510(k) clearance on record.