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 Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
510(k) Number K253013
Device Name Disposable Stone Retrieval Balloon Catheter
Applicant
Zhejiang Soudon Medical Technology Co., Ltd.
Rm. 302-1, Floor 3, Bldg. 4, #1 Nangonghe Rd.,
Donghu St., Linping District
Hangzhou,  CN 311100
Applicant Contact Junshi Wang
Correspondent
Shanghai Vanhe Consulting Co., Ltd.
2f, Bldg. #1, 3938 Huqingping Rd., Qingpu District
Shanghai,  CN 210703
Correspondent Contact Nick Wang
Regulation Number876.5010
Classification Product Code
GCA  
Date Received09/19/2025
Decision Date 05/08/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-