K220114 is an FDA 510(k) clearance for the PowerPAK Syringe. This device is classified as a Syringe, Antistick (Class II - Special Controls, product code MEG).
Submitted by Vault Paragon Group, Inc. (Oakland, US). The FDA issued a Cleared decision on January 25, 2023, 376 days after receiving the submission on January 14, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5860.
| 510(k) Number | K220114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 2022 |
| Decision Date | January 25, 2023 |
| Days to Decision | 376 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | MEG - Syringe, Antistick |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5860 |