FDA Product Code PON: Catheter, Balloon, Dilation Of Cervical Canal
Mechanical Dilation And Softening Of The Cervix.
Leading manufacturers include Gtimd, LLC.
4
Total
4
Cleared
195d
Avg days
2016
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Catheter, Balloon, Dilation Of Cervical Canal Devices (Product Code PON)
4 devices
About Product Code PON - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PON since 2016, with 4 receiving FDA clearance (average review time: 195 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
PON devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →