Cleared Traditional

SABA Tampons

K242105 · Essity Higiene Y Salud Mexico. S.A. DE C.V. · Obstetrics & Gynecology

Apr 2025

Decision

257d

Days

Class 2

Risk

About This 510(k) Submission

K242105 is an FDA 510(k) clearance for the SABA Tampons, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Essity Higiene Y Salud Mexico. S.A. DE C.V. (Cuidad De Mexico, MX). The FDA issued a Cleared decision on April 1, 2025, 257 days after receiving the submission on July 18, 2024. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K242105 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 18, 2024
Decision Date	April 01, 2025
Days to Decision	257 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.