510(k) K252337

Device
EdgeFlow Gel Pad
Applicant
Edgecare, Inc.
510(k) number
K252337
Product code
MUI
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2025-07-28
Regulation
892.1570
Classification name
Media, Coupling, Ultrasound
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Beom Ki Cha
Address
403, Teilhard Hall, 35, Baekbeom-Ro, Mapo-Gu Seoul KR 04107 04107

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code MUI

510(k)DeviceApplicantDecision date
K242167Sterile and Non-Sterile Ultrasonic Coupling AgentAnhui Deepblue Medical Technology Co., Ltd.2024-09-19
K241789Non-Sterile Ultrasound Transmission GelsHony Medical Co., Ltd.2024-07-24
K232957Sterile and Non-Sterile Ultrasound GelsJianerkang Medical Co., Ltd.2023-12-15
K221999Ultrasound Transmission GelsHony Medical Co., Ltd.2022-08-30
K211691Ultrast GelUltrast, Inc.2021-12-22
K190591Safergel Sterile Ultrasound GelSafersonic Us, Inc.2019-10-04
K181363EcoVue Sterile and Non-Sterile Ultrasound GelsH R Pharmaceuticals, Inc.2018-06-13
K163027Ultra/Phonic Free Conductivity GelPharmaceutical Innovations, Inc.2018-01-09
K163026Ultra/Phonic Scanning GelPharmaceutical Innovations, Inc.2018-01-09
K163024Ultra/Phonic Conductivity GelPharmaceutical Innovations, Inc.2018-01-08
K163023Other-Sonic Transmission GelPharmaceutical Innovations, Inc.2018-01-08
K163050Advance Medical Designs, Inc. Sterile Ultrasound GelAdvance Medical Designs, Inc.2017-10-25
K151070Sonishield 100 Antimicrobial Ultrasound GelQuotient Medical2016-01-13
K130581KONIX STERILE GELTurkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa2014-06-18
K131905SOLID GEL PADBluemtech2013-07-18