Revive Reusable Bladder Support— 510(k) K183468
Substantially EquivalentRinovum Subsidiary 2, LLC
FDA 510(k) clearance K183468 for Revive Reusable Bladder Support, Substantially Equivalent on 2019-01-25. Applicant: Rinovum Subsidiary 2, LLC.
Clearance details
- Applicant
- Rinovum Subsidiary 2, LLC
- Product code
- Code HHW
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroeville, PA, US
Adverse events under product code HHW
product code HHW- Malfunction
- 485
- Total
- 485
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.