FDA 510(k)

EndoFLIP

K-Number: K160725 · 2016-05-01

Decision Date2016-05-01

Product CodeFFX

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

EndoFLIP is the device name listed in this FDA 510(k) record. The listed applicant is Crospon, Ltd.. It received FDA 510(k) clearance on 2016-05-01 under 510(k) 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. The listed applicant is Crospon, Ltd.. The 510(k) number is K160725.

When did EndoFLIP receive FDA 510(k) clearance?

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

Who is the listed applicant for EndoFLIP?

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?

The FDA product code for EndoFLIP 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 System K172128EsoFLIP® ES-310 Balloon Catheter K170833EndoFLIP® System with FLIP Topography module

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Official Source

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