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

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.

Clearance details

Applicant: Ontex Bvba
Product code: Code HEB
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 ↗

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.