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FDA 510(k)

Ultrast Gel

K-Number: K211691 · 2021-12-22

ApplicantUltrast, Inc.
Decision Date2021-12-22
Product CodeMUI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Ultrast Gel is a medical device manufactured by Ultrast, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K211691. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ultrast Gel?

Ultrast Gel is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Ultrast, Inc.. The 510(k) number is K211691.

When was Ultrast Gel approved by the FDA?

Ultrast Gel received FDA 510(k) clearance on 2021-12-22, under approval number K211691.

What company makes Ultrast Gel?

Ultrast Gel is manufactured by Ultrast, Inc..

What is the FDA product code for Ultrast Gel?

The FDA product code for Ultrast Gel is MUI.

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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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