Cleared Special

COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS

K252939 · Cotton High Tech S.L. · Obstetrics & Gynecology

Oct 2025

Decision

24d

Days

Class 2

Risk

About This 510(k) Submission

K252939 is an FDA 510(k) clearance for the COHITECH ORGANIC COTTON COMPACT APPLICATOR 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 9, 2025, 24 days after receiving the submission on September 15, 2025. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5470.

Submission Details

510(k) Number	K252939 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2025
Decision Date	October 09, 2025
Days to Decision	24 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.