Glean Urodynamics System Male Delivery System (GUS-1000-M) +3 more— 510(k) K253537

Name: FDA 510(k) clearance K253537
Creator: U.S. Food and Drug Administration
Published: 2026-04-16

Substantially Equivalent

Bright Uro, Inc.

FDA 510(k) clearance K253537 for Glean Urodynamics System Male Delivery System (GUS-1000-M) +3 more, Substantially Equivalent on 2026-04-16. Applicant: Bright Uro, Inc.. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Bright Uro, Inc.
Product code: Code EXQ
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2025-11-13
Decision date: 2026-04-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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