K253537
- 510(k) number
- K253537
- Device name
- 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. CA · US
- Product code
- EXQ — Cystometer, Electrical Recording
- Decision date
- 2026-04-16
- Date received
- 2025-11-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K253537.pdf
Official FDA record: K253537
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.