FDA Product Code FFK: Lithotriptor, Electro-hydraulic
Leading manufacturers include Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. and Northgate Technologies, Inc..
FDA 510(k) Cleared Lithotriptor, Electro-hydraulic Devices (Product Code FFK)
About Product Code FFK - Regulatory Context
510(k) Submission Activity
61 total 510(k) submissions under product code FFK since 1980, with 61 receiving FDA clearance (average review time: 138 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under FFK have taken an average of 177 days to reach a decision - up from 137 days historically. Manufacturers should account for longer review timelines in current project planning.
FFK devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →