Tampax Tampons - (Light, Regular, Super and Super Plus Absorbencies)
by Procter & Gamble Co. 510(k)
Active
510(k) K061486
Overview
This device is a tampon, menstrual, unscented. It is classified as a Class II medical device under FDA regulation number 884.5470.
The device is supplied in various absorbencies including Light, Regular, Super, and Super Plus. It is intended for single-use menstrual management and has received FDA 510(k) clearance under K061486.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK061486 | Date1 Aug 2006 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 24 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HEB
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5470
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Procter & Gamble Co.
Questions
What is the Tampax tampon used for?
The Tampax tampon is intended for single-use menstrual management as an unscented menstrual device, designed to absorb menstrual flow during use.
How is the Tampax tampons supplied and what are their absorbency options?
Tampax tampons are supplied in four absorbency levels: Light, Regular, Super, and Super Plus, allowing users to select based on their menstrual flow needs.
Are Tampax tampons reusable or single-use?
Tampax tampons are intended for single-use only, meaning each tampon should be used once and then discarded to maintain hygiene and safety.
What regulatory pathway was used for the Tampax tampon's market authorization?
The Tampax tampon received market authorization through the FDA 510(k) clearance process under submission number K061486, demonstrating substantial equivalence to a legally marketed device.