FDA Product Code KNF: Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
Leading manufacturers include Gynesonics, Inc..
FDA 510(k) Cleared Coagulator-cutter, Endoscopic, Unipolar (and Accessories) Devices (Product Code KNF)
About Product Code KNF - Regulatory Context
510(k) Submission Activity
44 total 510(k) submissions under product code KNF since 1977, with 44 receiving FDA clearance (average review time: 187 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under KNF have taken an average of 85 days to reach a decision - down from 191 days historically, suggesting improved FDA processing for this classification.
KNF devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →