FDA.reportPublic FDA data

510(k) K230718

Device
UTC 3mL Medication Cartridge
Applicant
Gilero, LLC
510(k) number
K230718
Product code
MRZ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-15
Date received
2023-03-15
Regulation
880.5725
Classification name
Accessories, Pump, Infusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jessica Czamanski
Address
635 Davis Dr. Suite 100 Morrisville NC US 27560 27560

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MRZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220695Elite Biomedical Solutions Dose Request CordElite Biomedical Solutions2022-04-29
K201634RG 3ml Medication CartridgeChengdu Shifeng Medical Technology Co., Ltd.2021-03-26
K193654BlueStar RxWelldoc, Inc.2020-04-07
K191910SpaceStation MRIB. Braun Melsugen AG2020-03-12
K190013WellDoc BlueStarWelldoc, Inc.2019-11-04
K173531Lockbox for Perfusor Space PCA Infusion PumpB.Braun Medical, Inc.2018-08-02
K171346Sapphire SetsIcu Medical2017-08-25
K162532WellDoc BlueStar, WellDoc BlueStar RxWelldoc, Inc.2017-01-12
K160492Hospira Sapphire SetsHospira, Inc.2016-12-06
K162225WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx SystemWelldoc, Inc.2016-11-22
K142374ivWatch Model 400Ivwatch, LLC2015-02-13
K142333SMART LABEL, PROPOFOLAmerican I.V. Products, Inc. Dba Aiv, Inc.2014-12-18
K141273WELLDOC DIABETESMANAGER SYSTEM AND DIABETESMANAGER- RX SYSTEWelldoc, Inc.2014-07-08
K132618ONETOUCH REVEALLifescan, Inc.2013-12-16
K120209PATIENT CONTROLLED ANALGESIA (PCA) BUTTON CABLEAmerican I.V. Products, Inc.2012-04-12