MOONCUP, STYLE A & B— 510(k) K040335

Substantially Equivalent

Mooncup, LLC

FDA 510(k) clearance K040335 for MOONCUP, STYLE A & B, Substantially Equivalent on 2005-03-30. Applicant: Mooncup, LLC.

Clearance details

Applicant: Mooncup, LLC
Product code: Code HHE
Advisory panel: Obstetrics/Gynecology
Date received: 2004-02-11
Decision date: 2005-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, 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.