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 endoscope channel accessory
510(k) Number K220884
Device Name Disposable Endoscope Valve Sets
Applicant
SML Med-Tech Solutions Limited
Rm 406, Wah Yiu Indl Ctr, 30-32 Au Pui Wan St
Fo Tan, N.T.,  CN
Applicant Contact Mark Ko
Correspondent
Share Info (Guangzhou) Medical Consultant Ltd.
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Regulation Number876.1500
Classification Product Code
ODC  
Date Received03/28/2022
Decision Date 01/17/2023
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
-
-