U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS— 510(k) K112635

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K112635 for U BY KOTEX SLEEK UNSCENTED MENSTRUAL TAMPONS, Substantially Equivalent on 2011-10-07. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2011-09-09
Decision date: 2011-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Roswell, GA, US

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Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.