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)— 510(k) K253537

Substantially Equivalent

Bright Uro, Inc.

FDA 510(k) clearance K253537 for 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), Substantially Equivalent on 2026-04-16. Applicant: Bright Uro, Inc..

Clearance details

Applicant: Bright Uro, Inc.
Product code: Code EXQ
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-13
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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