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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Gilero, LLC. It received FDA 510(k) clearance on 2023-06-15 under 510(k) 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. The listed applicant is Gilero, LLC. The 510(k) number is K230718.

When did UTC 3mL Medication Cartridge receive FDA 510(k) clearance?

UTC 3mL Medication Cartridge received FDA 510(k) clearance on 2023-06-15, under 510(k) number K230718.

Who is the listed applicant for UTC 3mL Medication Cartridge?

The FDA 510(k) record lists Gilero, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UTC 3mL Medication Cartridge?

The FDA product code for UTC 3mL Medication Cartridge is MRZ.

Other records listing Gilero, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201936SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL

Related Devices (Code: MRZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220695Elite Biomedical Solutions Dose Request CordElite Biomedical SolutionsK201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.K193654BlueStar RxWelldoc, Inc.K191910SpaceStation MRIB. Braun Melsugen AGK190013WellDoc BlueStarWelldoc, Inc.K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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