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FDA 510(k)

Habib EUS RFA

K-Number: K161305 · 2016-07-07

ApplicantEmcision , Ltd.
Decision Date2016-07-07
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Habib EUS RFA is a medical device manufactured by Emcision , Ltd.. It received FDA 510(k) clearance on 2016-07-07 under approval number K161305. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Habib EUS RFA?

Habib EUS RFA is a medical device that received FDA 510(k) clearance on 2016-07-07. It is manufactured by Emcision , Ltd.. The 510(k) number is K161305.

When was Habib EUS RFA approved by the FDA?

Habib EUS RFA received FDA 510(k) clearance on 2016-07-07, under approval number K161305.

What company makes Habib EUS RFA?

Habib EUS RFA is manufactured by Emcision , Ltd..

What is the FDA product code for Habib EUS RFA?

The FDA product code for Habib EUS RFA is GEI.

Other Devices by Emcision , Ltd.

K180165Habib EndoHPB

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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.

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