FDA Product Code HDR: Cap, Cervical
Leading manufacturers include Rosesta Medical BV and Stepone Fertility Ltd (T/A B?a Fertility).
FDA 510(k) Cleared Cap, Cervical Devices (Product Code HDR)
About Product Code HDR - Regulatory Context
510(k) Submission Activity
29 total 510(k) submissions under product code HDR since 1981, with 29 receiving FDA clearance (average review time: 111 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under HDR have taken an average of 265 days to reach a decision - up from 106 days historically. Manufacturers should account for longer review timelines in current project planning.
HDR devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →