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FDA 510(k)

Aerin Medical Stylus

K-Number: K161994 · 2016-09-22

ApplicantAerin Medical, Inc.
Decision Date2016-09-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Aerin Medical Stylus 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 2016-09-22 under 510(k) number K161994. 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 Aerin Medical Stylus?

Aerin Medical Stylus is a medical device that received FDA 510(k) clearance on 2016-09-22. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K161994.

When did Aerin Medical Stylus receive FDA 510(k) clearance?

Aerin Medical Stylus received FDA 510(k) clearance on 2016-09-22, under 510(k) number K161994.

Who is the listed applicant for Aerin Medical Stylus?

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 Aerin Medical Stylus?

The FDA product code for Aerin Medical Stylus is GEI.

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Other records listing Aerin Medical, Inc. as applicant

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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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