Super Plus Tampons
FDA 510(k) K864652 · Tambrands, Inc.
510(k) numberK864652
Submission
- Device name
- Super Plus Tampons
- Applicant
- Tambrands, Inc.
Palmer, MA, US - Received
- November 26, 1986
- Decision date
- March 4, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HEB – Tampon, Menstrual, Unscented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5470
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code HEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
More from Unibeauty (Hubei) Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K962476 | Unscented Menstrual Tampon, Plastic ApplicatorHEB · Traditional | 08/13/1996SE |
| K960341 | Tampax Tampon with Additive Junior,Regular,Super, and Super PlusHEB · Traditional | 04/17/1996SE |
| K952344 | Satin Touch Deodorant Tampon Junior, Regular, Super, Super PlusHIL · Traditional | 07/28/1995SE |
| K944834 | Unscented Menstrual TamponsHEB · Traditional | 12/21/1994SE |
| K924303 | Tampax Tampon, Regular AbsorbencyHEB · Traditional | 07/29/1993SE |
| K923932 | Tampax Tampons, Super AbsorbencyHEB · Traditional | 07/29/1993SE |
| K896989 | Tampax TamponHEB · Traditional | 12/22/1989SE |
| K896115 | Tampon, Petal Soft Plastic Appli., Deodorant SuperHIL · Traditional | 12/13/1989SE |
| K896114 | Tampon, Petal Soft Plastic Appli., Super Absorb.HEB · Traditional | 12/13/1989SE |
| K896113 | Tampon, Petal Soft Plastic Applicator, Super PlusHEB · Traditional | 12/13/1989SE |
Questions and answers
When was Super Plus Tampons cleared by the FDA?
Super Plus Tampons (K864652) received a 510(k) decision of Substantially Equivalent on March 4, 1987, 98 days after the submission was received.
What is the product code of K864652?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.