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Regulatory Details

The EndoFLIP® Imaging System is CE-marked and FDA approved, and is available for sale.

PDF Icon  EndoFLIP EF/BF325 510k Clearance

PDF Icon  EndoFLIP EF800 510k Clearance

PDF Icon  EndoFLIP EF900 510k Clearance

PDF Icon  EndoFLIP EF620 510k Clearance

PDF Icon  EndoFLIP EF-325L 510k Clearance

PDF Icon  EndoFLIP Barostat 510k Clearance

PDF Icon  EndoFLIP Extended Indications 510k Clearance

PDF Icon  EsoFLIP 510k Clearance - Achalasia

PDF Icon  EsoFLIP 510k Clearance - Strictures

PDF Icon  FDA - Affirmations of Compliance

PDF Icon  Crospon ISO13485 Quality System Certification

PDF Icon  EndoFLIP CE Certificate

PDF Icon  EndoFLIP Declaration of Conformity

PDF Icon  EndoFLIP Electrical Safety Certification

PDF Icon  EndoFLIP Australian TGA Certification

PDF Icon  EndoFLIP Canadian Medical Device Certification

PDF Icon  EsoFLIP Canadian Medical Device Certificate

PDF Icon  Korean KFDA Quality System Certification

Crospon®, FLIP® and EndoFLIP® are registered trademarks of Crospon Ltd.


 
EndoFLIP® Technology
Introduction
Technology behind EndoFLIP®
Regulatory Details
General Clinical Papers
User Manuals
Trouble Shooting Guide
         
EndoFLIP logo   Crospon (USA) 701 Palomar Airport Rd, Carlsbad, CA 92011, USA. Phone: 1-855-CROSPON
Crospon (EU) Galway Business Park, Dangan, Galway, H91 P2DK, Ireland. Phone +353-91-519880