U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS— 510(k) K091749

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K091749 for U BY KOTEX CLICK* UNSCENTED TAMPONS, MODEL ABSORBENCY: REGULAR, SUPER AND SUPER PLUS, Substantially Equivalent on 2009-12-23. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2009-06-16
Decision date: 2009-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, US

Download summary PDF View on FDA.gov ↗

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.