KOTEX SECURITY TUBE TAMPONS— 510(k) K885194

Substantially Equivalent

Kimberly-Clark Corp.

FDA 510(k) clearance K885194 for KOTEX SECURITY TUBE TAMPONS, Substantially Equivalent on 1989-03-01. Applicant: Kimberly-Clark Corp..

Clearance details

Applicant: Kimberly-Clark Corp.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 1988-12-16
Decision date: 1989-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.