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FDA 510(k)

GyroStim

K-Number: K220231 · 2022-04-27

ApplicantUltrathera Technologies, Inc.
Decision Date2022-04-27
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

GyroStim is a medical device manufactured by Ultrathera Technologies, Inc.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220231. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GyroStim?

GyroStim is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Ultrathera Technologies, Inc.. The 510(k) number is K220231.

When was GyroStim approved by the FDA?

GyroStim received FDA 510(k) clearance on 2022-04-27, under approval number K220231.

What company makes GyroStim?

GyroStim is manufactured by Ultrathera Technologies, Inc..

What is the FDA product code for GyroStim?

The FDA product code for GyroStim is LXV.

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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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