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FDA 510(k)

EndoFLIP System

K-Number: K183072 · 2019-02-15

ApplicantCrospon, Ltd.
Decision Date2019-02-15
Product CodeFFX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EndoFLIP System is a medical device manufactured by Crospon, Ltd.. It received FDA 510(k) clearance on 2019-02-15 under approval number K183072. 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?

EndoFLIP System is a medical device that received FDA 510(k) clearance on 2019-02-15. It is manufactured by Crospon, Ltd.. The 510(k) number is K183072.

When was EndoFLIP System approved by the FDA?

EndoFLIP System received FDA 510(k) clearance on 2019-02-15, under approval number K183072.

What company makes EndoFLIP System?

EndoFLIP System is manufactured by Crospon, Ltd..

What is the FDA product code for EndoFLIP System?

The FDA product code for EndoFLIP System is FFX.

Other Devices by Crospon, Ltd.

K160725EndoFLIP K172128EsoFLIP® ES-310 Balloon Catheter K170833EndoFLIP® System with FLIP Topography module

Related Devices (Code: FFX)

K160170Lehman Manometry CatheterWilson-Cook Medical, Inc. K160725EndoFLIPCrospon, Ltd. K151086ManoScan SystemGiven Imaging , Ltd. K170833EndoFLIP® System with FLIP Topography moduleCrospon, Ltd. K160287Rapid Barostat Bag (RBB) Pump and CatheterMui Scientific K181750SITZMARKSKonsyl Pharmaceuticals

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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