Cleared Traditional

PowerPAK Syringe

K220114 · Vault Paragon Group, Inc. · General Hospital

Jan 2023

Decision

376d

Days

Class 2

Risk

About This 510(k) Submission

K220114 is an FDA 510(k) clearance for the PowerPAK Syringe, 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 review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K220114 FDA.gov
FDA Decision	Cleared 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