Product code EXQ— Gastroenterology, Urology
ADVANCE MODEL UDS-ADV
- Classification name
- Cystometer, Electrical Recording
- Device class
- Class 2
- Regulation
- 21 CFR 876.1620
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code EXQ
FDA has cleared devices under product code EXQ between 1978 and 2026, filed by 7 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2026
- 2025
- 1993
- 1988
- 1981
- 1978
Top applicants under product code EXQ
Recent clearances under product code EXQ
- K253537 — Glean Urodynamics System Male Delivery System (GUS-1000-M) +3 more
- K243052 — Glean Urodynamics System Male Delivery System (GUS-1000-M) +2 more
- K931282 — VOLUME TRANSDUCER
- K931574 — ADVANCE MODEL UDS-ADV
- K920574 — CAMSYS 6300
- K880391 — DACOMED CYSTOMETER
- K812177 — LIFE-TECH #1857 PRESSURE/POLOT MODULE
- K781032 — AQUA-GEL
Data sourced from openFDA. This site is unofficial and independent of the FDA.