SABA Tampons— 510(k) K242105

Substantially Equivalent

Essity Higiene Y Salud Mexico. S.A. DE C.V.

FDA 510(k) clearance K242105 for SABA Tampons, Substantially Equivalent on 2025-04-01. Applicant: Essity Higiene Y Salud Mexico. S.A. DE C.V..

Clearance details

Applicant: Essity Higiene Y Salud Mexico. S.A. DE C.V.
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2024-07-18
Decision date: 2025-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cuidad De Mexico, MX

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.