FDA Product Code EXQ: Cystometer, Electrical Recording
Leading manufacturers include Bright Uro, Inc..
8
Total
8
Cleared
166d
Avg days
1978
Since
Growing category -
2 submissions in the last 2 years
vs 0 in the prior period
Consistent review times:
166d avg (recent)
FDA 510(k) Cleared Cystometer, Electrical Recording Devices (Product Code EXQ)
8 devices
Cleared
Apr 16, 2026
Glean Urodynamics System Male Delivery System (GUS-1000-M)
Bright Uro, Inc.
Gastroenterology & Urology
154d
Cleared
Mar 24, 2025
Glean Urodynamics System Male Delivery System (GUS-1000-M)
Bright Uro, Inc.
Gastroenterology & Urology
178d
About Product Code EXQ - Regulatory Context
510(k) Submission Activity
8 total 510(k) submissions under product code EXQ since 1978, with 8 receiving FDA clearance (average review time: 166 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - EXQ Product Code
FDA review times for EXQ submissions have been consistent, averaging 166 days recently vs 166 days historically.
EXQ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →