FDA Product Code FBO: Cystourethroscope
Leading manufacturers include Karl Storz SE & CO. KG.
FDA 510(k) Cleared Cystourethroscope Devices (Product Code FBO)
About Product Code FBO - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code FBO since 1985, with 19 receiving FDA clearance (average review time: 160 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
Recent submissions under FBO have taken an average of 77 days to reach a decision - down from 170 days historically, suggesting improved FDA processing for this classification.
FBO devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →