MELUNA CLASSIC/SPORT MENSTRUAL CUP— 510(k) K140626

Substantially Equivalent

Meluna

FDA 510(k) clearance K140626 for MELUNA CLASSIC/SPORT MENSTRUAL CUP, Substantially Equivalent on 2014-07-10. Applicant: Meluna.

Clearance details

Applicant: Meluna
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 2014-03-11
Decision date: 2014-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

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.