SABA Tampons
K-Number: K242105 · 2025-04-01
Decision Date2025-04-01
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
SABA Tampons is a medical device manufactured by Essity Higiene Y Salud Mexico. S.A. DE C.V.. It received FDA 510(k) clearance on 2025-04-01 under approval 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. It is manufactured by Essity Higiene Y Salud Mexico. S.A. DE C.V.. The 510(k) number is K242105.
When was SABA Tampons approved by the FDA?
SABA Tampons received FDA 510(k) clearance on 2025-04-01, under approval number K242105.
What company makes SABA Tampons?
SABA Tampons is manufactured by Essity Higiene Y Salud Mexico. S.A. DE C.V..
What is the FDA product code for SABA Tampons?
The FDA product code for SABA Tampons is HEB.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.