FDA Product Code FAS: Electrode, Electrosurgical, Active, Urological
Leading manufacturers include Dornier Medtech America, Inc., Olympus Winter & Ibe GmbH and Lamidey Noury Medical.
FDA 510(k) Cleared Electrode, Electrosurgical, Active, Urological Devices (Product Code FAS)
About Product Code FAS - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code FAS since 1990, with 58 receiving FDA clearance (average review time: 140 days).
Submission volume has increased in recent years - 3 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 FAS submissions have been consistent, averaging 150 days recently vs 139 days historically.
FAS devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →