FDA Product Code HHK: Curette, Suction, Endometrial (and Accessories)
Leading manufacturers include Li Medical Corporation , Ltd. and Gcmedica Enterprise Ltd.(Wuxi).
FDA 510(k) Cleared Curette, Suction, Endometrial (and Accessories) Devices (Product Code HHK)
About Product Code HHK - Regulatory Context
510(k) Submission Activity
42 total 510(k) submissions under product code HHK since 1976, with 42 receiving FDA clearance (average review time: 111 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 HHK have taken an average of 171 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
HHK devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →