Glean Urodynamics System Male Delivery System (GUS-1000-M) +2 more— 510(k) K243052

Name: FDA 510(k) clearance K243052
Creator: U.S. Food and Drug Administration
Published: 2025-03-24

Substantially Equivalent

Bright Uro, Inc.

FDA 510(k) clearance K243052 for Glean Urodynamics System Male Delivery System (GUS-1000-M) +2 more, Substantially Equivalent on 2025-03-24. 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))
Applicant: Bright Uro, Inc.
Product code: Code EXQ
Device class: Class 2
Regulation: 21 CFR 876.1620
Advisory panel: Gastroenterology, Urology
Date received: 2024-09-27
Decision date: 2025-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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