Cleared Abbreviated

Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)

K223376 · Cardinal Health200, LLC · General Hospital

Jun 2023

Decision

229d

Days

Class 2

Risk

About This 510(k) Submission

K223376 is an FDA 510(k) clearance for the Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130), a Syringe, Antistick (Class II — Special Controls, product code MEG), submitted by Cardinal Health200, LLC (Waukegan, US). The FDA issued a Cleared decision on June 21, 2023, 229 days after receiving the submission on November 4, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number	K223376 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 04, 2022
Decision Date	June 21, 2023
Days to Decision	229 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF