ONTEX AND OTHER PROPRIETARY NAMES— 510(k) K122603

Substantially Equivalent

Ontex Bvba

FDA 510(k) clearance K122603 for ONTEX AND OTHER PROPRIETARY NAMES, Substantially Equivalent on 2012-12-19. Applicant: Ontex Bvba.

Clearance details

Applicant: Ontex Bvba
Product code: Code HEB
Advisory panel: Obstetrics/Gynecology
Date received: 2012-08-27
Decision date: 2012-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Old Lyme, CT, US

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.