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FDA 510(k)

EsoFLIP® ES-310 Balloon Catheter

K-Number: K172128 · 2017-11-22

ApplicantCrospon, Ltd.
Decision Date2017-11-22
Product CodePIE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

EsoFLIP® ES-310 Balloon Catheter is a medical device manufactured by Crospon, Ltd.. It received FDA 510(k) clearance on 2017-11-22 under approval number K172128. The device is classified under product code PIE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EsoFLIP® ES-310 Balloon Catheter?

EsoFLIP® ES-310 Balloon Catheter is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Crospon, Ltd.. The 510(k) number is K172128.

When was EsoFLIP® ES-310 Balloon Catheter approved by the FDA?

EsoFLIP® ES-310 Balloon Catheter received FDA 510(k) clearance on 2017-11-22, under approval number K172128.

What company makes EsoFLIP® ES-310 Balloon Catheter?

EsoFLIP® ES-310 Balloon Catheter is manufactured by Crospon, Ltd..

What is the FDA product code for EsoFLIP® ES-310 Balloon Catheter?

The FDA product code for EsoFLIP® ES-310 Balloon Catheter is PIE.

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Other Devices by Crospon, Ltd.

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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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