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 Device, Vascular, For Promoting Embolization
510(k) Number K252812
Device Name UniPearls® Embolic Microspheres
Applicant
Suzhou Haowei Medical Technology Co., Ltd.
Rm. 304, Bldg. 4, Tianyun Sq., 111 Wusongjiang Ave.
Wuzhong District
Suzhou,  CN 215124
Applicant Contact Jinyan Shi
Correspondent
Suzhou Haowei Medical Technology Co., Ltd.
Rm. 304, Bldg. 4, Tianyun Sq., 111 Wusongjiang Ave.
Wuzhong District
Suzhou,  CN 215124
Correspondent Contact Jinyan Shi
Regulation Number870.3300
Classification Product Code
KRD  
Date Received09/04/2025
Decision Date 07/31/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-