FDA Product Code HEB: Tampon, Menstrual, Unscented
An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.
Leading manufacturers include Unibeauty (Hubei) Technology Co., Ltd., Tosama, D.O.O. and Suzhou Borage Medical Technology Co., Ltd..
FDA 510(k) Cleared Tampon, Menstrual, Unscented Devices (Product Code HEB)
About Product Code HEB - Regulatory Context
510(k) Submission Activity
189 total 510(k) submissions under product code HEB since 1978, with 189 receiving FDA clearance (average review time: 114 days).
Submission volume has remained relatively stable over the observed period, with 7 submissions in the last 24 months.
FDA Review Time
Recent submissions under HEB have taken an average of 143 days to reach a decision - up from 113 days historically. Manufacturers should account for longer review timelines in current project planning.
HEB devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →