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 K221331
Device Name Disposable Endoscope Valves System
Applicant
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd.
Changzhou,  CN 213149
Applicant Contact Wang Qi
Correspondent
Changzhou Endoclean Medical Device Co., Ltd.
West Side Of 4th Floor, Bldg. E2, #9 Changyang Rd.
Changzhou,  CN 213149
Correspondent Contact Wang Qi
Regulation Number876.1500
Classification Product Code
ODC  
Date Received05/05/2022
Decision Date 09/08/2022
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
-
-