Skip to content

U by Kotex Sleek Unscented Menstrual Tampons

by Kimberly-Clark Corp.

510(k) K112635

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK112635 Date7 Oct 2011ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0750-2019 FDA Class II initiated 11 Dec 2018
    • Terminated Z-0751-2019 FDA Class II initiated 11 Dec 2018
    • Terminated Z-0748-2019 FDA Class II initiated 11 Dec 2018
    • Terminated Z-0749-2019 FDA Class II initiated 11 Dec 2018

    Potential for tampon to come apart upon removal.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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 Kimberly-Clark Corporation

See all devices from Kimberly-Clark Corporation →