Cleared Traditional

Cohitech Organic Cotton Non-Applicator Cottonlock Tampons

K211775 · Cotton High Tech S.L. · Obstetrics & Gynecology

Oct 2021

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K211775 is an FDA 510(k) clearance for the Cohitech Organic Cotton Non-Applicator Cottonlock Tampons, a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB), submitted by Cotton High Tech S.L. (Balsareny, ES). The FDA issued a Cleared decision on October 22, 2021, 135 days after receiving the submission on June 9, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K211775 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 09, 2021
Decision Date	October 22, 2021
Days to Decision	135 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HEB — Tampon, Menstrual, Unscented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5470
Definition	An Unscented Menstrual Tampon Is A Plug Made Of Cellulosic Or Synthetic Material That Is Inserted Into The Vagina And Used To Absorb Menstrual Fluid Or Other Vaginal Discharge.