FDA Product Code
FDA Product Code EXQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.1620
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253537 | 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) | Bright Uro, Inc. | 2026-04-16 | Traditional | PDF ↗ |
| K243052 | 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)) | Bright Uro, Inc. | 2025-03-24 | Traditional | PDF ↗ |
| K931282 | VOLUME TRANSDUCER | Life-Tech Intl., Inc. | 1993-09-17 | Traditional | PDF ↗ |
| K931574 | ADVANCE MODEL UDS-ADV | Laborie Medical Technologies, Ltd. | 1993-08-05 | Traditional | PDF ↗ |
| K920574 | CAMSYS 6300 | F.M. Wiest USA, Inc. | 1993-02-17 | Traditional | PDF ↗ |
| K880391 | DACOMED CYSTOMETER | Dacomed Corp. | 1988-04-27 | Traditional | PDF ↗ |
| K812177 | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Life-Tech Instruments, Inc. | 1981-09-09 | Traditional | PDF ↗ |
| K781032 | AQUA-GEL | Murray, Salk, Inc. | 1978-12-15 | Traditional | PDF ↗ |
Product code EXQ · Class II · Gastroenterology, Urology. Data: openFDA.