Cleared Traditional

Ultrast Gel

K211691 · Ultrast, Inc. · Radiology

Dec 2021

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K211691 is an FDA 510(k) clearance for the Ultrast Gel, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Ultrast, Inc. (Oceanside, US). The FDA issued a Cleared decision on December 22, 2021, 203 days after receiving the submission on June 2, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K211691 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 2021
Decision Date	December 22, 2021
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF