FDA 510(k) Applications for Medical Device Product Code "EXQ"
(Cystometer, Electrical Recording)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K243052 | Bright Uro, Inc. | 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)) | 03/24/2025 |
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