Unscented W long plastic and cardboard applicator tampons— 510(k) K191666

Name: FDA 510(k) clearance K191666
Creator: U.S. Food and Drug Administration
Published: 2019-12-20

Substantially Equivalent

Ontex Bvba

FDA 510(k) clearance K191666 for Unscented W long plastic and cardboard applicator tampons, Substantially Equivalent on 2019-12-20. Applicant: Ontex Bvba. Device class: 2.

Clearance details

Applicant: Ontex Bvba
Product code: Code HEB
Device class: Class 2
Regulation: 21 CFR 884.5470
Advisory panel: Obstetrics/Gynecology
Date received: 2019-06-21
Decision date: 2019-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buggenhout Oost - Vlaanderen, BE

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEB

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K252005 — Livi Device2026-03-20
K253719 — Unscented Menstrual Long Applicator Tampon +2 more2025-12-17
K252939 — COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS2025-10-09
K252613 — Unscented menstrual three-piece applicator tampon2025-09-19
K251033 — Unscented menstrual long applicator tampon +3 more2025-08-13

More clearances from Ontex Bvba

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K162746 — Ontex and other proprietary names2017-03-03
K142786 — Ontex Unscented Tampons with Colored Plastic Applicators2015-06-23
K132595 — ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS2014-04-23
K132208 — ONTEX AND OTHERS PROPRIETARY NAMES2014-04-10
K122603 — ONTEX AND OTHER PROPRIETARY NAMES2012-12-19

Adverse events under product code HEB

product code HEB

Injury: 329
Malfunction: 5,647
Total: 5,976

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.