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 Ureteroscope And Accessories, Flexible/Rigid
510(k) Number K250917
Device Name Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8)
Applicant
Shenzhen Sanping Image Technology Co., Ltd.
Room 203, No.634, Shajing Road, Buchong Community,
Shajing Street, Bao’an District
Shenzhen,  CN 518104
Applicant Contact Chen Salon
Correspondent
IMD Medical & Drug technology service institutions
Room 308, Building 11, No. 23 Jinqu Road, Wanjiang District
Dongguan,  CN 523000
Correspondent Contact Chen Salon
Regulation Number876.1500
Classification Product Code
FGB  
Date Received03/27/2025
Decision Date 10/31/2025
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
-
-