Cleared Special

Cohitech Cottonlock Tampons with Reusable Applicator

K220238 · Cotton High Tech S.L. · Obstetrics & Gynecology

Feb 2022

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K220238 is an FDA 510(k) clearance for the Cohitech Cottonlock Tampons with Reusable Applicator, 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 February 25, 2022, 28 days after receiving the submission on January 28, 2022. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K220238 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 2022
Decision Date	February 25, 2022
Days to Decision	28 days
Submission Type	Special
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.