Cleared Traditional

ONTEX AND OTHERS PROPRIETARY NAMES

K132208 · Ontex Bvba · Obstetrics & Gynecology

Apr 2014

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K132208 is an FDA 510(k) clearance for the ONTEX AND OTHERS PROPRIETARY NAMES, a Tampon, Menstrual, Scented, Scented-deodorized (Class II — Special Controls, product code HIL), submitted by Ontex Bvba (The Hague, NL). The FDA issued a Cleared decision on April 10, 2014, 268 days after receiving the submission on July 16, 2013. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5460.

Submission Details

510(k) Number	K132208 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2013
Decision Date	April 10, 2014
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF

Device Classification

Product Code	HIL — Tampon, Menstrual, Scented, Scented-deodorized
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 884.5460
Definition	A Scented Or Scented-deodorized 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.