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MUI — Media, Coupling, Ultrasound Class II

FDA Device Classification

Classification Details

Product Code
MUI
Device Class
Class II
Regulation Number
892.1570
Submission Type
Review Panel
RA
Medical Specialty
Radiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242167anhui deepblue medical technology coSterile and Non-Sterile Ultrasonic Coupling AgentSeptember 19, 2024
K241789hony medical coNon-Sterile Ultrasound Transmission GelsJuly 24, 2024
K232957jianerkang medical coSterile and Non-Sterile Ultrasound GelsDecember 15, 2023
K221999hony medical coUltrasound Transmission GelsAugust 30, 2022
K211691ultrastUltrast GelDecember 22, 2021
K190591safersonic usSafergel Sterile Ultrasound GelOctober 4, 2019
K181363h r pharmaceuticalsEcoVue Sterile and Non-Sterile Ultrasound GelsJune 13, 2018
K163026pharmaceutical innovationsUltra/Phonic Scanning GelJanuary 9, 2018
K163027pharmaceutical innovationsUltra/Phonic Free Conductivity GelJanuary 9, 2018
K163024pharmaceutical innovationsUltra/Phonic Conductivity GelJanuary 8, 2018
K163023pharmaceutical innovationsOther-Sonic Transmission GelJanuary 8, 2018
K163050advance medical designsAdvance Medical Designs, Inc. Sterile Ultrasound GelOctober 25, 2017
K151070quotient medicalSonishield 100 Antimicrobial Ultrasound GelJanuary 13, 2016
K130581turkuaz saglik hizmetleri medikal temizlik kimyasaKONIX STERILE GELJune 18, 2014
K131905bluemtechSOLID GEL PADJuly 18, 2013
K130041sheathing technologiesSHEATHES STERILE ULTRASOUND GELFebruary 6, 2013
K121311cloverline international pharma servicesTHIXO-GEL ULTRASOUND SPRAYAugust 30, 2012
K112827sheathing technologiesSHEATHES ULTRASOND GELJune 22, 2012
K102637dynarex corporationDYNAREX ULTRASOUND GELFebruary 16, 2011
K102683ob the-additionTHE ADDITIONJanuary 6, 2011