FDA Product Code HHE: Cup, Menstrual
A Menstrual Cup Is A Receptacle Placed In The Vagina To Collect Menstrual Flow.
Leading manufacturers include Menstrual Mates and CooperSurgical, Inc..
16
Total
16
Cleared
216d
Avg days
1981
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Cup, Menstrual Devices (Product Code HHE)
16 devices
Cleared
Jun 21, 2024
Sunny Cup and Applicator
Menstrual Mates
Obstetrics & Gynecology
266d
Cleared
Apr 18, 1991
DIAGNOSTIC HYSTEROSCOPY REDIKIT (TM)
CooperSurgical, Inc.
Obstetrics & Gynecology
86d
About Product Code HHE - Regulatory Context
510(k) Submission Activity
16 total 510(k) submissions under product code HHE since 1981, with 16 receiving FDA clearance (average review time: 216 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.