MOONCUP— 510(k) K060852

Name: FDA 510(k) clearance K060852
Creator: U.S. Food and Drug Administration
Published: 2006-12-26

Substantially Equivalent

Mooncup Limited

FDA 510(k) clearance K060852 for MOONCUP, Substantially Equivalent on 2006-12-26. Applicant: Mooncup Limited. Device class: 2.

Clearance details

Applicant: Mooncup Limited
Product code: Code HHE
Device class: Class 2
Regulation: 21 CFR 884.5400
Advisory panel: Obstetrics/Gynecology
Date received: 2006-03-28
Decision date: 2006-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brighton, GB

Download summary PDF View on FDA.gov ↗

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K140626 — MELUNA CLASSIC/SPORT MENSTRUAL CUP2014-07-10
K121857 — FEMMYCYCLE2012-11-15
K120107 — SCKOONCUP2012-09-18
K112165 — RHEA CUP2012-05-24

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.