FDA Product Code FHN: Ligator, Hemorrhoidal
Leading manufacturers include Beijing Zksk Technology Co., Ltd..
22
Total
22
Cleared
116d
Avg days
1980
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Ligator, Hemorrhoidal Devices (Product Code FHN)
22 devices
About Product Code FHN - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code FHN since 1980, with 22 receiving FDA clearance (average review time: 116 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
FHN devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →