FDA Product Code HHW: Pessary, Vaginal
Leading manufacturers include Watkins-Conti Products, Inc., Reia, LLC and Resilia, Inc..
FDA 510(k) Cleared Pessary, Vaginal Devices (Product Code HHW)
About Product Code HHW - Regulatory Context
510(k) Submission Activity
41 total 510(k) submissions under product code HHW since 1977, with 41 receiving FDA clearance (average review time: 205 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for HHW submissions have been consistent, averaging 183 days recently vs 214 days historically.
HHW devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →