FDA Product Code HDC: Tenaculum, Uterine
Leading manufacturers include Aspivix SA.
20
Total
20
Cleared
87d
Avg days
1989
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Tenaculum, Uterine Devices (Product Code HDC)
20 devices
Cleared
Jan 25, 2023
Carevix™ Suction Cervical Stabilizer
Aspivix SA
Obstetrics & Gynecology
33d
Cleared
Aug 17, 2021
ASPIVIX v1.1 Cervical Suction Tenaculum
Aspivix SA
Obstetrics & Gynecology
231d
About Product Code HDC - Regulatory Context
510(k) Submission Activity
20 total 510(k) submissions under product code HDC since 1989, with 20 receiving FDA clearance (average review time: 87 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
HDC devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →