U BY KOTEX CLICK* UNSCENTED TAMPONS - Super
by Kimberly-Clark Corp. 510(k)
Active
510(k) K091749
Overview
U by Kotex Click Unscented Tampons are menstrual devices designed for internal use to absorb menstrual flow. They are available in Regular, Super, and Super Plus absorbencies to meet different flow needs.
These tampons are supplied in compact packaging for portability and are intended for single-use application. The device is FDA 510(k) cleared with product code HEB and is classified under Obstetrics/Gynecology medical specialty.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK091749 | Date23 Dec 2009 | 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- Withdrawn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
- Models / Variants
- Super
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.5470
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Kimberly-Clark Corporation
Questions
Are these tampons reusable or designed for single-use only?
These tampons are explicitly designed for single-use only, as stated in the description. Each tampon is intended to be used once and then discarded to maintain hygiene and safety standards.
What absorbency levels are available for the U by Kotex Click Unscented Tampons?
The U by Kotex Click Unscented Tampons come in three absorbency levels: Regular, Super, and Super Plus. These options cater to varying menstrual flow needs during a cycle.
How are these tampons packaged, and why is this important?
These tampons are supplied in compact packaging, which enhances portability. This design is particularly useful for users who need discreet and convenient access to menstrual products during daily activities or travel.
What regulatory pathway was followed for FDA clearance of these tampons?
The U by Kotex Click Unscented Tampons were cleared through the FDA’s 510(k) process, specifically under the Traditional clearance type. The device was determined to be substantially equivalent to a predicate product and falls under the Obstetrics/Gynecology medical specialty with product code HEB.
Are these tampons unscented, and what does that mean for users?
Yes, these tampons are explicitly labeled as unscented, meaning they do not contain added fragrances. This feature is particularly beneficial for users who may experience irritation, allergies, or sensitivity to scented products, ensuring a gentler experience during use.