Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K252237
Device Name EdgeFlow UW20
Applicant
Edgecare, Inc.
403, Teilhard Hall, 35, Baekbeom-Ro, Mapo-Gu
Seoul,  KR 04107
Applicant Contact Beom Ki Cha
Correspondent
Edgecare, Inc.
12F, 8 Yangpyeong-ro 25-gil, Yeongdeungpo-gu
Seoul,  KR 07207
Correspondent Contact Beom Ki Cha
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Codes
ITX   QIH  
Date Received07/17/2025
Decision Date 04/17/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-