FDA 510(k)

U by Kotex Click Unscented Menstrual Tampons

K-Number: K172118 · 2017-10-11

Decision Date2017-10-11

Product CodeHEB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

U by Kotex Click Unscented Menstrual Tampons is a medical device manufactured by Kimberly-Clark Corporation. It received FDA 510(k) clearance on 2017-10-11 under approval number K172118. 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 U by Kotex Click Unscented Menstrual Tampons?

U by Kotex Click Unscented Menstrual Tampons is a medical device that received FDA 510(k) clearance on 2017-10-11. It is manufactured by Kimberly-Clark Corporation. The 510(k) number is K172118.

When was U by Kotex Click Unscented Menstrual Tampons approved by the FDA?

U by Kotex Click Unscented Menstrual Tampons received FDA 510(k) clearance on 2017-10-11, under approval number K172118.

What company makes U by Kotex Click Unscented Menstrual Tampons?

U by Kotex Click Unscented Menstrual Tampons is manufactured by Kimberly-Clark Corporation.

What is the FDA product code for U by Kotex Click Unscented Menstrual Tampons?

The FDA product code for U by Kotex Click Unscented Menstrual Tampons is HEB.

Related Clinical Trials

NCT07561905 Tampon Safety-in-Use Study RECRUITING

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Related Devices (Code: HEB)

K161877Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, RegularOpal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super, Opal by Femtex Pull & Snap and Private Label Unscented Compact Applicator Tampon, Super PlFirst Quality Hygienic, Inc. K162746Ontex and other proprietary namesOntex Bvba K181911Interlude 100% Cotton TamponAlbaad Fem K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem K180167Playtex Stella TamponsPlaytex Manufacturing, Inc.

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.