Cleared Traditional

UTC 3mL Medication Cartridge

K230718 · Gilero, LLC · General Hospital

Jun 2023

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K230718 is an FDA 510(k) clearance for the UTC 3mL Medication Cartridge, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Gilero, LLC (Morrisville, US). The FDA issued a Cleared decision on June 15, 2023, 92 days after receiving the submission on March 15, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K230718 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2023
Decision Date	June 15, 2023
Days to Decision	92 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF