Panels › Gastroenterology, Urology › Product code EXQ · Class 2
Cystometer, Electrical Recording
Regulation 876.1620
1510(k)s in 12 months (8 all time)
0recalls in 12 months (1 all time)
0recalls that name a 510(k)
Top companies in EXQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Bright Uro, Inc. | 2 | 0 |
| Dacomed Corp. | 1 | 0 |
| F.M. Wiest USA, Inc. | 1 | 0 |
| Laborie Medical Technologies, Ltd. | 1 | 0 |
| Laborie Medical Technologies Cor | 0 | 1 |
| Life-Tech Instruments, Inc. | 1 | 0 |
| Life-Tech Intl., Inc. | 1 | 0 |
| Murray, Salk, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 16, 2026 | K253537 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F) Bright Uro, Inc. | EXQ |
| Mar 24, 2025 | K243052 | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics System Female Delivery System (GUS-1000-F) Bright Uro, Inc. | EXQ |
| Sep 17, 1993 | K931282 | VOLUME TRANSDUCER Life-Tech Intl., Inc. | EXQ |
| Aug 5, 1993 | K931574 | ADVANCE MODEL UDS-ADV Laborie Medical Technologies, Ltd., CA | EXQ |
| Feb 17, 1993 | K920574 | CAMSYS 6300 F.M. Wiest USA, Inc. | EXQ |
| Apr 27, 1988 | K880391 | DACOMED CYSTOMETER Dacomed Corp. | EXQ |
| Sep 9, 1981 | K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE Life-Tech Instruments, Inc. | EXQ |
| Dec 15, 1978 | K781032 | AQUA-GEL Murray, Salk, Inc. | EXQ |
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