510(k) K243052

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)) by Bright Uro, Inc. — Product Code EXQ

K243052 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))". The FDA issued a decision of Substantially Equivalent on March 24, 2025. 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.