U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS— 510(k) K103311

Substantially Equivalent

Kimberly Clark Corporation

FDA 510(k) clearance K103311 for U BY KOTEX CLICK UNSCENTED MENSTRUL TAMPONS, Substantially Equivalent on 2010-12-10. Applicant: Kimberly Clark Corporation.

Clearance details

Applicant: Kimberly Clark Corporation
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2010-11-10
Decision date: 2010-12-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Neenah, WI, 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.