• 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 choledochoscope and accessories, flexible/rigid
510(k) Number K222261
Device Name Flexible Video-Choledochoscope System
Applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd
3 Floor, Building No.1, 4299 JinDu Road, Minhang District
Shanghai,  CN 201108
Applicant Contact Yihua Ma
Correspondent
Shanghai SeeGen Photoelectric Technology Co., Ltd
3 Floor, Building No.1, 4299 JinDu Road, Minhang District
Shanghai,  CN 201108
Correspondent Contact Yihua Ma
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
FET   KQM   NTN  
Date Received07/28/2022
Decision Date 04/20/2023
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
-
-