FDA Product Code FAN: Sigmoidoscope, Rigid, Electrical
Leading manufacturers include Surgease Innovations Limited.
2
Total
2
Cleared
112d
Avg days
1983
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Sigmoidoscope, Rigid, Electrical Devices (Product Code FAN)
2 devices
About Product Code FAN - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code FAN since 1983, with 2 receiving FDA clearance (average review time: 112 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FAN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →