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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 a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2019-12-20 under approval 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. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K192471.

When was RHIN1 Stylus approved by the FDA?

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

What company makes RHIN1 Stylus?

RHIN1 Stylus is manufactured by Aerin Medical, Inc..

What is the FDA product code for RHIN1 Stylus?

The FDA product code for RHIN1 Stylus is GEI.

Other Devices by Aerin Medical, Inc.

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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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