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.

Summary

Bright Uro's record names four Glean Urodynamics System components: a Male Delivery System (GUS-1000-M), a Female Delivery System (GUS-1000-F), a Uroflowmeter (UFM-1000), and an Abdominal Sensor (GUS-1000-A). All four are filed under product code EXQ (Cystometer, Electrical Recording).

Class II, 21 CFR 876.1620. Gastroenterology and Urology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Bright Uro filed from Irvine, California. The decision came 154 calendar days after FDA received it (November 13, 2025 to April 16, 2026).

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: Product 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 ↗

Recent devices under product code EXQ

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K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M) +2 more2025-03-24
K931282 — VOLUME TRANSDUCER1993-09-17
K931574 — ADVANCE MODEL UDS-ADV1993-08-05
K920574 — CAMSYS 63001993-02-17
K880391 — DACOMED CYSTOMETER1988-04-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.