THE DIVACUP MENSTRUAL SOLUTION— 510(k) K021356

Substantially Equivalent

Diva International, Inc.

FDA 510(k) clearance K021356 for THE DIVACUP MENSTRUAL SOLUTION, Substantially Equivalent on 2002-07-16. Applicant: Diva International, Inc..

Clearance details

Applicant: Diva International, Inc.
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 2002-04-29
Decision date: 2002-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kitchener Ontario, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code HHE

product code HHE

Injury: 344
Total: 344

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.