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 K192588
Device Name G-EYE System
Applicant
SMART Medical Systems Ltd.
5 HaNofar St.
Raanana,  IL 4366404
Applicant Contact Adva Yoselzon
Correspondent
Hogan Lovells US LPP
1735 Market Street
Floor 23
Philladelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.1500
Classification Product Code
FDF  
Date Received09/19/2019
Decision Date 04/15/2020
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
-
-