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FDA 510(k)

EndoFLIP

K-Number: K160725 · 2016-05-01

ApplicantCrospon, Ltd.
Decision Date2016-05-01
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoFLIP is a medical device manufactured by Crospon, Ltd.. It received FDA 510(k) clearance on 2016-05-01 under approval number K160725. 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?

EndoFLIP is a medical device that received FDA 510(k) clearance on 2016-05-01. It is manufactured by Crospon, Ltd.. The 510(k) number is K160725.

When was EndoFLIP approved by the FDA?

EndoFLIP received FDA 510(k) clearance on 2016-05-01, under approval number K160725.

What company makes EndoFLIP?

EndoFLIP is manufactured by Crospon, Ltd..

What is the FDA product code for EndoFLIP?

The FDA product code for EndoFLIP is FFX.

Other Devices by Crospon, Ltd.

K172128EsoFLIP® ES-310 Balloon Catheter K170833EndoFLIP® System with FLIP Topography module K183072EndoFLIP System

Related Devices (Code: FFX)

K160170Lehman Manometry CatheterWilson-Cook Medical, Inc. K151086ManoScan SystemGiven Imaging , Ltd. K170833EndoFLIP® System with FLIP Topography moduleCrospon, 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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