FDA Product Code EXQ: Cystometer, Electrical Recording
Leading manufacturers include Bright Uro, Inc..
FDA 510(k) Cleared Cystometer, Electrical Recording Devices (Product Code EXQ)
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 Review Time
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 →