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 Gastrointesinal Lesion Software Detection System
510(k) Number K211326
Device Name EndoScreener
Applicant
Chengdu Wision Medical Device Co., LTD.
Unit 802, Floor 8, Building 17, Yintaicheng, No. 1999 Yizhou
Road, Wuhou District
Chengdu,  CN 610041
Applicant Contact JingJia Liu
Correspondent
Hogan Lovells US LLP
555 Thirteenth St, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number876.1520
Classification Product Code
QNP  
Date Received04/30/2021
Decision Date 11/19/2021
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
Predetermined Change
Control Plan Authorized		 No
-
-