Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cohitech Reusable Tampon Applicator

K-Number: K212479 · 2021-10-08

ApplicantCotton High Tech S.L.
Decision Date2021-10-08
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Cohitech Reusable Tampon Applicator is a medical device manufactured by Cotton High Tech S.L.. It received FDA 510(k) clearance on 2021-10-08 under approval number K212479. 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 Cohitech Reusable Tampon Applicator?

Cohitech Reusable Tampon Applicator is a medical device that received FDA 510(k) clearance on 2021-10-08. It is manufactured by Cotton High Tech S.L.. The 510(k) number is K212479.

When was Cohitech Reusable Tampon Applicator approved by the FDA?

Cohitech Reusable Tampon Applicator received FDA 510(k) clearance on 2021-10-08, under approval number K212479.

What company makes Cohitech Reusable Tampon Applicator?

Cohitech Reusable Tampon Applicator is manufactured by Cotton High Tech S.L..

What is the FDA product code for Cohitech Reusable Tampon Applicator?

The FDA product code for Cohitech Reusable Tampon Applicator is HEB.

Other Devices by Cotton High Tech S.L.

K182813COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT K211775Cohitech Organic Cotton Non-Applicator Cottonlock Tampons K220238Cohitech Cottonlock Tampons with Reusable Applicator K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

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 K180850re.t.a Reuseable Tampon ApplicatorThinx, Inc. K173225Interlude and private label Unscented 3-piece compact applicator tamponAlbaad Fem

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.

↑