Cleared Traditional

Safergel Sterile Ultrasound Gel

K190591 · Safersonic Us, Inc. · Radiology

Oct 2019

Decision

211d

Days

Class 2

Risk

About This 510(k) Submission

K190591 is an FDA 510(k) clearance for the Safergel Sterile Ultrasound Gel, a Media, Coupling, Ultrasound (Class II — Special Controls, product code MUI), submitted by Safersonic Us, Inc. (Highland Park, US). The FDA issued a Cleared decision on October 4, 2019, 211 days after receiving the submission on March 7, 2019. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1570.

Submission Details

510(k) Number	K190591 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 07, 2019
Decision Date	October 04, 2019
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement