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FDA 510(k)

EndoFLIP® System with FLIP Topography module

K-Number: K170833 · 2017-04-17

ApplicantCrospon, Ltd.
Decision Date2017-04-17
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoFLIP® System with FLIP Topography module is a medical device manufactured by Crospon, Ltd.. It received FDA 510(k) clearance on 2017-04-17 under approval number K170833. The device is classified under product code FFX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndoFLIP® System with FLIP Topography module?

EndoFLIP® System with FLIP Topography module is a medical device that received FDA 510(k) clearance on 2017-04-17. It is manufactured by Crospon, Ltd.. The 510(k) number is K170833.

When was EndoFLIP® System with FLIP Topography module approved by the FDA?

EndoFLIP® System with FLIP Topography module received FDA 510(k) clearance on 2017-04-17, under approval number K170833.

What company makes EndoFLIP® System with FLIP Topography module?

EndoFLIP® System with FLIP Topography module is manufactured by Crospon, Ltd..

What is the FDA product code for EndoFLIP® System with FLIP Topography module?

The FDA product code for EndoFLIP® System with FLIP Topography module is FFX.

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Other Devices by Crospon, Ltd.

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Related Devices (Code: FFX)

K160170Lehman Manometry CatheterWilson-Cook Medical, Inc. K160725EndoFLIPCrospon, Ltd. K151086ManoScan SystemGiven Imaging , Ltd. K160287Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific K181750SITZMARKSKonsyl Pharmaceuticals K191087IntraMarX Radiopaque MarkersAnx Robotica Corp

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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