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 K200173
Device Name Stone Retrieval Balloon
Applicant
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Applicant Contact Chunqi Han
Correspondent
Hangzhou AGS MedTech Co., Ltd.
Building 5, Building 6, No.597 Kangxin Road Yuhang District
Hangzhou,  CN 311106
Correspondent Contact Chunqi Han
Regulation Number876.5010
Classification Product Code
GCA  
Date Received01/23/2020
Decision Date 05/01/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-