PowerPAK Syringe— 510(k) K220114
Substantially EquivalentVault Paragon Group, Inc.
FDA 510(k) clearance K220114 for PowerPAK Syringe, Substantially Equivalent on 2023-01-25. Applicant: Vault Paragon Group, Inc..
Clearance details
- Applicant
- Vault Paragon Group, Inc.
- Product code
- Code MEG
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oakland, CA, US
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
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.