Intimate Rose Vaginal Dilators— 510(k) K241748
Substantially EquivalentPlus EV Holdings Dba Intimate Rose
FDA 510(k) clearance K241748 for Intimate Rose Vaginal Dilators, Substantially Equivalent on 2024-08-14. Applicant: Plus EV Holdings Dba Intimate Rose.
Clearance details
- Applicant
- Plus EV Holdings Dba Intimate Rose
- Product code
- Code HDX
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Kansas City, MO, US
Adverse events under product code HDX
product code HDX- Other
- 1
- Total
- 1
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.