Nutrifit— 510(k) K243361
Substantially EquivalentVygon USA
FDA 510(k) clearance K243361 for Nutrifit, Substantially Equivalent on 2024-12-19. Applicant: Vygon USA.
Clearance details
- Applicant
- Vygon USA
- Product code
- Code FPD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lansdale Montgomery, PA, US
Adverse events under product code FPD
product code FPD- Death
- 6
- Other
- 1
- Total
- 7
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.