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FDA 510(k)

InSure ONE

K-Number: K170548 · 2017-10-05

ApplicantEnterix, Inc.
Decision Date2017-10-05
Product CodeKHE
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

InSure ONE is a medical device manufactured by Enterix, Inc.. It received FDA 510(k) clearance on 2017-10-05 under approval number K170548. The device is classified under product code KHE. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InSure ONE?

InSure ONE is a medical device that received FDA 510(k) clearance on 2017-10-05. It is manufactured by Enterix, Inc.. The 510(k) number is K170548.

When was InSure ONE approved by the FDA?

InSure ONE received FDA 510(k) clearance on 2017-10-05, under approval number K170548.

What company makes InSure ONE?

InSure ONE is manufactured by Enterix, Inc..

What is the FDA product code for InSure ONE?

The FDA product code for InSure ONE is KHE.

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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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