UTC 3mL Medication Cartridge
K-Number: K230718 · 2023-06-15
ApplicantGilero, LLC
Decision Date2023-06-15
Product CodeMRZ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
UTC 3mL Medication Cartridge is a medical device manufactured by Gilero, LLC. It received FDA 510(k) clearance on 2023-06-15 under approval number K230718. The device is classified under product code MRZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the UTC 3mL Medication Cartridge?
UTC 3mL Medication Cartridge is a medical device that received FDA 510(k) clearance on 2023-06-15. It is manufactured by Gilero, LLC. The 510(k) number is K230718.
When was UTC 3mL Medication Cartridge approved by the FDA?
UTC 3mL Medication Cartridge received FDA 510(k) clearance on 2023-06-15, under approval number K230718.
What company makes UTC 3mL Medication Cartridge?
UTC 3mL Medication Cartridge is manufactured by Gilero, LLC.
What is the FDA product code for UTC 3mL Medication Cartridge?
The FDA product code for UTC 3mL Medication Cartridge is MRZ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.