FDA 510(k)

Ultrast Gel

Numéro K : K211691 · 2021-12-22

Date de décision2021-12-22

Code produitMUI

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

Ultrast Gel is the device name listed in this FDA 510(k) record. The listed applicant is Ultrast, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K211691. The device is classified under product code MUI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Ultrast Gel?

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

When did Ultrast Gel receive FDA 510(k) clearance?

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

Who is the listed applicant for Ultrast Gel?

The FDA 510(k) record lists Ultrast, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ultrast Gel?

The FDA product code for Ultrast Gel is MUI.

Essais cliniques associés

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Dispositifs connexes (Code : MUI)

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Source officielle

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