ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS— 510(k) K132595

Substantially Equivalent

Ontex Bvba

FDA 510(k) clearance K132595 for ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS, Substantially Equivalent on 2014-04-23. Applicant: Ontex Bvba.

Clearance details

Applicant: Ontex Bvba
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2013-08-19
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Hague, NL

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.