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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 the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2017-04-17 under 510(k) 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. The listed applicant is Crospon, Ltd.. The 510(k) number is K170833.

When did EndoFLIP® System with FLIP Topography module receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoFLIP® System with FLIP Topography module?

The FDA 510(k) record lists Crospon, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Crospon, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K183072EndoFLIP SystemK172128EsoFLIP® ES-310 Balloon CatheterK160725EndoFLIP

Related Devices (Code: FFX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252605mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001)Medspira, LLCK240007Solar Compact (G4-1)Laborie Medical Technologies, Corp.K231861EndoflipTM 300 SystemCovidien, LLCK223705EndoflipTM 300Covidien, LLCK222000Transit-PelletsMedifactia ABK201106IntraMarX 3D Radiopaque MarkerAnx 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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