EndoFLIP® System With FLIP Topography Module

System, Gastrointestinal Motility (electrical)

Crospon Ltd.

The following data is part of a premarket notification filed by Crospon Ltd. with the FDA for Endoflip® System With Flip Topography Module.

Pre-market Notification Details

• Device ID: K170833
• 510k Number: K170833
• Device Name: EndoFLIP® System With FLIP Topography Module
• Classification: System, Gastrointestinal Motility (electrical)
• Applicant: Crospon Ltd. Galway Business Park, Dangan Galway, IE
• Contact: John O’dea
• Correspondent: Paul Dryden; Crospon Ltd., C/oProMedic, LLC 24301 Woodsage Dr. Bonita Springs, FL 34135
• Product Code: FFX
• CFR Regulation Number: 876.1725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-20
• Decision Date: 2017-04-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05391530810142	K170833	000