HEB
- Product code
- HEB
- Device name
- Tampon, Menstrual, Unscented
- Device class
- Class 2
- 21 CFR
- 21 CFR 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 189
FDA classification definition
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.
510(k) clearances, last 3 years (10)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K252005 | 2026-03-20 | Liviwell, Inc. | Livi Device summary |
| K253719 | 2025-12-17 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented Menstrual Long Applicator Tampon; Unscente summary |
| K252939 | 2025-10-09 | Cotton High Tech S.L. | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS summary |
| K252613 | 2025-09-19 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented menstrual three-piece applicator tampon summary |
| K251033 | 2025-08-13 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented menstrual long applicator tampon; Unscente summary |
| K242105 | 2025-04-01 | Essity Higiene Y Salud Mexico. S.A. DE | SABA Tampons summary |
| K241064 | 2025-01-10 | Shandong Intco Hygiene Products Co., L | Unscented Tampon summary |
| K240708 | 2024-05-10 | Suzhou Borage Medical Technology Co., | Organic Cotton Tampon; Organic Cotton PESCVcord Tamp summary |
| K232060 | 2024-04-12 | Tosama, D.O.O. | TOSAMA Reusable Applicator summary |
| K232598 | 2023-12-15 | Unibeauty (Hubei) Technology Co., Ltd. | Unscented Menstrual Tampon summary |
Official FDA classification page: HEB
Classification and pathway per current FDA publications. Data from openFDA (CC0).