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 Choledochoscope And Accessories, Flexible/Rigid
510(k) Number K221784
Device Name Single-use Video Pancreaticobiliary Scope, PB Digital Controller
Applicant
Micro-Tech (Nanjing) Co., Ltd
No. 10 Gaoke Third Road
Nanjing National Hi-tech Industrial Development Zone
Nanjing,  CN 210032
Applicant Contact Sally He
Correspondent
Micro-Tech (Nanjing) Co., Ltd
No. 10 Gaoke Third Road
Nanjing National Hi-tech Industrial Development Zone
Nanjing,  CN 210032
Correspondent Contact Sally He
Regulation Number876.1500
Classification Product Code
FBN  
Subsequent Product Codes
KQM   NTN  
Date Received06/21/2022
Decision Date 02/16/2023
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
-
-