FDA Product Code MKO: Falloposcope
Leading manufacturers include Femdx Medsystems, Inc..
4
Total
4
Cleared
177d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Falloposcope Devices (Product Code MKO)
4 devices
About Product Code MKO - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code MKO since 1997, with 4 receiving FDA clearance (average review time: 177 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MKO devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →