FDA Product Code LKF: Cannula, Manipulator/injector, Uterine
Leading manufacturers include Femasys, Inc., Li Medical Corporation , Ltd. and CooperSurgical, Inc..
FDA 510(k) Cleared Cannula, Manipulator/injector, Uterine Devices (Product Code LKF)
About Product Code LKF - Regulatory Context
510(k) Submission Activity
87 total 510(k) submissions under product code LKF since 1978, with 87 receiving FDA clearance (average review time: 194 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LKF have taken an average of 136 days to reach a decision - down from 198 days historically, suggesting improved FDA processing for this classification.
LKF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →