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 Gastroscope And Accessories, Flexible/Rigid
510(k) Number K113166
Device Name CLEARPATH UPPER GI
Applicant
Easyglide , Ltd.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
Easyglide , Ltd.
24301 Woodsage Dr.
Bonita Springs,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.1500
Classification Product Code
FDS  
Date Received10/27/2011
Decision Date 05/16/2012
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
Predetermined Change
Control Plan Authorized		 No
-
-