EXQ
- Product code
- EXQ
- Device name
- Cystometer, Electrical Recording
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1620
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 8 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253537 | 2026-04-16 | Bright Uro, Inc. | Glean Urodynamics System Male Delivery System (GUS-1 | |
| K243052 | 2025-03-24 | Bright Uro, Inc. | Glean Urodynamics System Male Delivery System (GUS-1 |
Official FDA classification page: EXQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).