FDA 510(k)

re.t.a Reuseable Tampon Applicator

K-Number: K180850 · 2018-08-20

Decision Date2018-08-20

Product CodeHEB

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

re.t.a Reuseable Tampon Applicator is a medical device manufactured by Thinx, Inc.. It received FDA 510(k) clearance on 2018-08-20 under approval 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. It is manufactured by Thinx, Inc.. The 510(k) number is K180850.

When was re.t.a Reuseable Tampon Applicator approved by the FDA?

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

What company makes re.t.a Reuseable Tampon Applicator?

re.t.a Reuseable Tampon Applicator is manufactured by Thinx, Inc..

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)

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. K172118U by Kotex Click Unscented Menstrual TamponsKimberly-Clark Corporation K162746Ontex and other proprietary namesOntex Bvba K181911Interlude 100% Cotton TamponAlbaad Fem 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.