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 Colonoscope And Accessories, Flexible/Rigid
510(k) Number K210981
Device Name Pure Vu System
Applicant
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel,  IL 3902638
Applicant Contact Mark Pomeranz
Correspondent
Motus GI Medical Technologies Ltd.
22 Keren Ha'yesod Str.
Tirat Carmel,  IL 3902638
Correspondent Contact Mark Pomeranz
Regulation Number876.1500
Classification Product Code
FDF  
Subsequent Product Code
FDS  
Date Received04/01/2021
Decision Date 04/29/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
-
-