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FDA 510(k)

U by Kotex® Click® Unscented Menstrual Tampons

K-Number: K223749 · 2023-01-06

Decision Date2023-01-06
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

U by Kotex® Click® Unscented Menstrual Tampons is the device name listed in this FDA 510(k) record. The listed applicant is Kimberly-Clark Corporation. It received FDA 510(k) clearance on 2023-01-06 under 510(k) number K223749. 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 2023-01-06. The listed applicant is Kimberly-Clark Corporation. The 510(k) number is K223749.

When did U by Kotex® Click® Unscented Menstrual Tampons receive FDA 510(k) clearance?

U by Kotex® Click® Unscented Menstrual Tampons received FDA 510(k) clearance on 2023-01-06, under 510(k) number K223749.

Who is the listed applicant for U by Kotex® Click® Unscented Menstrual Tampons?

The FDA 510(k) record lists Kimberly-Clark Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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.

Other records listing Kimberly-Clark Corporation as applicant

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.

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.

Official Source

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