Regular Petal Soft Plastic Applicator Tampons
by Tambrands Inc. 510(k)
Active
510(k) K864649
Overview
This device is a menstrual tampon with a plastic applicator, classified as a tampon, menstrual, unscented under product code HEB. It is designed for the absorption of menstrual flow.
It is supplied as a single-use device and has received FDA 510(k) clearance under K864649, granted on March 4, 1987, following a traditional review. The device is classified as Class II and is subject to special controls.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK864649 | Date4 Mar 1987 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HEB
- FDA applicant
- Tambrands, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5470
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Tambrands Inc.
Questions
What is this device used for?
It is a menstrual tampon designed for the absorption of menstrual flow. It features a plastic applicator and is intended for single use during menstruation.
How is it supplied?
The device is supplied as a single-use tampon with a plastic applicator. It is manufactured by Tambrands Inc. and distributed in the United States.
Is it scented?
No, it is unscented. The product is classified under the unscented category to minimize irritation and allergic reactions for sensitive users.
What is the regulatory classification?
It is a Class II medical device under FDA product code HEB, subject to special controls. It received 510(k) clearance under K864649 on March 4, 1987.
Can it be reused?
No, it is strictly single-use. Reuse increases risk of infection and compromises structural integrity. Each unit is disposed of after one insertion and removal.