Medical Device Manufacturer · US , Old Lyme , CT

Ontex Bvba

6 submissions · 6 cleared · Since 2012

Total

Cleared

Denied

Ontex Bvba — FDA 510(k) Submissions

Ontex Bvba has submitted 6 FDA 510(k) premarket notifications since 2012, of which 6 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Tampon, Menstrual, Unscented, Tampon, Menstrual, Scented, Scented-deodorized . Use the specialty filter in the sidebar to narrow results.

6 devices

1–6 of 6

Unscented W long plastic and cardboard applicator tampons

K191666 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology

Dec 2019 182d

Ontex and other proprietary names

K162746 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology

Mar 2017 154d

Ontex Unscented Tampons with Colored Plastic Applicators

K142786 · HEB Tampon, Menstrual, Unscented · Obstetrics & Gynecology

Jun 2015 270d

ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS