Sunny Cup and Applicator— 510(k) K233361
Substantially EquivalentMenstrual Mates
FDA 510(k) clearance K233361 for Sunny Cup and Applicator, Substantially Equivalent on 2024-06-21. Applicant: Menstrual Mates.
Clearance details
- Applicant
- Menstrual Mates
- Product code
- Code HHE
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lewes, DE, US
Adverse events under product code HHE
product code HHE- Injury
- 344
- Total
- 344
Source: openFDA MAUDE database, through . 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.