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FDA 510(k)

InSeca ARC Stylus, Aerin Console

K-Number: K162810 · 2017-01-11

ApplicantAerin Medical, Inc.
Decision Date2017-01-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InSeca ARC Stylus, Aerin Console is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2017-01-11 under 510(k) number K162810. 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 InSeca ARC Stylus, Aerin Console?

InSeca ARC Stylus, Aerin Console is a medical device that received FDA 510(k) clearance on 2017-01-11. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K162810.

When did InSeca ARC Stylus, Aerin Console receive FDA 510(k) clearance?

InSeca ARC Stylus, Aerin Console received FDA 510(k) clearance on 2017-01-11, under 510(k) number K162810.

Who is the listed applicant for InSeca ARC Stylus, Aerin Console?

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

What is the FDA product code for InSeca ARC Stylus, Aerin Console?

The FDA product code for InSeca ARC Stylus, Aerin Console is GEI.

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Other records listing Aerin Medical, Inc. as applicant

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Related Devices (Code: GEI)

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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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