Renova RP Centesis Pump— 510(k) K221042
Substantially EquivalentGi Supply, Inc.
FDA 510(k) clearance K221042 for Renova RP Centesis Pump, Substantially Equivalent on 2023-04-19. Applicant: Gi Supply, Inc..
Clearance details
- Applicant
- Gi Supply, Inc.
- Product code
- Code BTA
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mechanicsburg, PA, US
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.