Device Listing 1753859111
Listing Summary#
- Listing key
- 1753859111
- Premarket submission
- K243052
- 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))
- Applicant
- Bright Uro, Inc.
- Product code
- EXQ
- Decision date
- 2025-03-24