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FDA 510(k)

SABA Tampons

K-Number: K242105 · 2025-04-01

ApplicantEssity Higiene Y Salud Mexico. S.A. DE C.V.
Decision Date2025-04-01
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SABA Tampons is the device name listed in this FDA 510(k) record. The listed applicant is Essity Higiene Y Salud Mexico. S.A. DE C.V.. It received FDA 510(k) clearance on 2025-04-01 under 510(k) number K242105. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SABA Tampons?

SABA Tampons is a medical device that received FDA 510(k) clearance on 2025-04-01. The listed applicant is Essity Higiene Y Salud Mexico. S.A. DE C.V.. The 510(k) number is K242105.

When did SABA Tampons receive FDA 510(k) clearance?

SABA Tampons received FDA 510(k) clearance on 2025-04-01, under 510(k) number K242105.

Who is the listed applicant for SABA Tampons?

The FDA 510(k) record lists Essity Higiene Y Salud Mexico. S.A. DE C.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SABA Tampons?

The FDA product code for SABA Tampons is HEB.

Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K241064Unscented TamponShandong Intco Hygiene Products Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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