FDA 510(k)

Habib EndoHPB

K-Number: K180165 · 2018-03-20

Decision Date2018-03-20

Product CodeKNS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Habib EndoHPB is a medical device manufactured by Emcision , Ltd.. It received FDA 510(k) clearance on 2018-03-20 under approval number K180165. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Habib EndoHPB?

Habib EndoHPB is a medical device that received FDA 510(k) clearance on 2018-03-20. It is manufactured by Emcision , Ltd.. The 510(k) number is K180165.

When was Habib EndoHPB approved by the FDA?

Habib EndoHPB received FDA 510(k) clearance on 2018-03-20, under approval number K180165.

What company makes Habib EndoHPB?

Habib EndoHPB is manufactured by Emcision , Ltd..

What is the FDA product code for Habib EndoHPB?

The FDA product code for Habib EndoHPB is KNS.

Other Devices by Emcision , Ltd.

K161305Habib EUS RFA

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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.