EXQ — Cystometer, Electrical Recording Class II
FDA product code EXQ covers "Cystometer, Electrical Recording", a Class II medical device regulated under 21 CFR 876.1620. Submissions are reviewed by the Gastroenterology, Urology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EXQ
- Device Class
- Class II
- Regulation Number
- 876.1620
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253537 | Bright Uro | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy | Apr 16, 2026 |
| K243052 | Bright Uro | Glean Urodynamics System Male Delivery System (GUS-1000-M); Glean Urodynamics Sy | Mar 24, 2025 |
| K931282 | Life-Tech Intl | VOLUME TRANSDUCER | Sep 17, 1993 |
| K931574 | Laborie Medical Technologies | ADVANCE MODEL UDS-ADV | Aug 5, 1993 |
| K920574 | F.M. Wiest Usa | CAMSYS 6300 | Feb 17, 1993 |
| K880391 | Dacomed | DACOMED CYSTOMETER | Apr 27, 1988 |
| K812177 | Life-Tech Instruments | LIFE-TECH #1857 PRESSURE/POLOT MODULE | Sep 9, 1981 |
| K781032 | Murray, Salk | AQUA-GEL | Dec 15, 1978 |