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FDA 510(k)

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)

K-Number: K253537 · 2026-04-16

ApplicantBright Uro, Inc.
Decision Date2026-04-16
Product CodeEXQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

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) is the device name listed in this FDA 510(k) record. The listed applicant is Bright Uro, Inc.. It received FDA 510(k) clearance on 2026-04-16 under 510(k) number K253537. The device is classified under product code EXQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 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)?

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) is a medical device that received FDA 510(k) clearance on 2026-04-16. The listed applicant is Bright Uro, Inc.. The 510(k) number is K253537.

When did 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) receive FDA 510(k) clearance?

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) received FDA 510(k) clearance on 2026-04-16, under 510(k) number K253537.

Who is the listed applicant 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)?

The FDA 510(k) record lists Bright Uro, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code 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)?

The FDA product code 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) is EXQ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05694793Trial for Reliability of Urodynamics SysTemACTIVE_NOT_RECRUITINGNCT07485205Establishing Normative Urodynamics Parameters for the Glean Urodynamics System in Healthy AdultsRECRUITINGNCT05466955Slashing Two-wheeled Accidents by Leveraging EyecareACTIVE_NOT_RECRUITINGNCT05498376The Leadless AV Versus DDD Pacing StudyACTIVE_NOT_RECRUITINGNCT05995613Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of ColorCOMPLETEDNCT07542886A Study to Learn How Different Injector Pens Affect the Study Medicine Called Genotropin (Somatropin) Delivery and Taken up Into the Blood in Healthy AdultsCOMPLETED

Other records listing Bright Uro, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))

Related Devices (Code: EXQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243052Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F); Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))Bright Uro, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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