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FDA 510(k)

RHIN1 Stylus

K-Number: K192471 · 2019-12-20

ApplicantAerin Medical, Inc.
Decision Date2019-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RHIN1 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 2019-12-20 under 510(k) number K192471. 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 RHIN1 Stylus?

RHIN1 Stylus is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K192471.

When did RHIN1 Stylus receive FDA 510(k) clearance?

RHIN1 Stylus received FDA 510(k) clearance on 2019-12-20, under 510(k) number K192471.

Who is the listed applicant for RHIN1 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 RHIN1 Stylus?

The FDA product code for RHIN1 Stylus is 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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