LUNETTE MENSTRUAL CUP, MODELS 1 AND 2— 510(k) K091754

Substantially Equivalent

Lune Group , Ltd.

FDA 510(k) clearance K091754 for LUNETTE MENSTRUAL CUP, MODELS 1 AND 2, Substantially Equivalent on 2009-11-13. Applicant: Lune Group , Ltd..

Clearance details

Applicant: Lune Group , Ltd.
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 2009-06-16
Decision date: 2009-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

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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.