K243052 is an FDA 510(k) clearance for the 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)). This device is classified as a Cystometer, Electrical Recording (Class II - Special Controls, product code EXQ).
Submitted by Bright Uro, Inc. (Irvine, US). The FDA issued a Cleared decision on March 24, 2025, 178 days after receiving the submission on September 27, 2024.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1620.
| 510(k) Number | K243052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2024 |
| Decision Date | March 24, 2025 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EXQ — Cystometer, Electrical Recording |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1620 |