Device Listing 1074196865
Listing Summary#
- Listing key
- 1074196865
- Premarket submission
- K253537
- Device
- 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
- EXQ
- Decision date
- 2026-04-16