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FDA 510(k)

re.t.a Reuseable Tampon Applicator

K-Number: K180850 · 2018-08-20

ApplicantThinx, Inc.
Decision Date2018-08-20
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

re.t.a Reuseable Tampon Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Thinx, Inc.. It received FDA 510(k) clearance on 2018-08-20 under 510(k) number K180850. 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 re.t.a Reuseable Tampon Applicator?

re.t.a Reuseable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2018-08-20. The listed applicant is Thinx, Inc.. The 510(k) number is K180850.

When did re.t.a Reuseable Tampon Applicator receive FDA 510(k) clearance?

re.t.a Reuseable Tampon Applicator received FDA 510(k) clearance on 2018-08-20, under 510(k) number K180850.

Who is the listed applicant for re.t.a Reuseable Tampon Applicator?

The FDA 510(k) record lists Thinx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for re.t.a Reuseable Tampon Applicator?

The FDA product code for re.t.a Reuseable Tampon Applicator 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.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

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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