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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 the device name listed in this FDA 510(k) record. The listed applicant is Enterix, Inc.. It received FDA 510(k) clearance on 2017-10-05 under 510(k) 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. The listed applicant is Enterix, Inc.. The 510(k) number is K170548.

When did InSure ONE receive FDA 510(k) clearance?

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

Who is the listed applicant for InSure ONE?

The FDA 510(k) record lists Enterix, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InSure ONE?

The FDA product code for InSure ONE is KHE.

Related Devices (Code: KHE)

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.

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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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