Tampon, Rely Modified
by Procter & Gamble Mfg. Co. 510(k)
Active
510(k) K780243
Overview
A tampon is a menstrual device designed to absorb menstrual flow. This device is classified as a tampon, menstrual, unscented under FDA device classification.
It was cleared via the FDA 510(k) process under K780243, granted on March 2, 1978, and is classified as a Class II medical device. The product is supplied non-sterile and intended for single-use vaginal absorption of menstrual fluid.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780243 | Date2 Mar 1978 | 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- Withdrawn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
- 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 TAMPON RELY MODIFIED used for?
The TAMPON RELY MODIFIED is a menstrual device designed to absorb menstrual flow through vaginal insertion, intended for single-use management of menstruation.
How is the TAMPON RELY MODIFIED supplied and is it sterile?
The TAMPON RELY MODIFIED is supplied non-sterile and is intended for single-use only, meaning it should not be reused after initial insertion and removal.
What regulatory pathway was used to clear the TAMPON RELY MODIFIED?
The TAMPON RELY MODIFIED was cleared through the FDA 510(k) traditional process under submission K780243, which determined it to be substantially equivalent to a legally marketed predicate device.