510(k) K253537 ยท EXQ Cystometer, Electrical Recording
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., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 16, 2026 |
| Received | Nov 13, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253537
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.