Cleared Traditional

K132595 - ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS
(FDA 510(k) Clearance)

K132595 · Ontex Bvba · Obstetrics & Gynecology

Apr 2014

Decision

247d

Days

Class 2

Risk

K132595 is an FDA 510(k) clearance for the ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS. This device is classified as a Tampon, Menstrual, Unscented (Class II — Special Controls, product code HEB).

Submitted by Ontex Bvba (The Hague, NL). The FDA issued a Cleared decision on April 23, 2014, 247 days after receiving the submission on August 19, 2013.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5470. 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..

Submission Details

510(k) Number	K132595 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 19, 2013
Decision Date	April 23, 2014
Days to Decision	247 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.