510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K190591Substantially Equivalent

Safergel Sterile Ultrasound Gel

Safersonic US, Inc., Highland Park IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K190591 is the FDA 510(k) clearance record for Safergel Sterile Ultrasound Gel, a class II device, cleared for Safersonic Us, Inc. on under FDA product code MUI (Media, Coupling, Ultrasound). FDA records list one 510(k) clearance for Safersonic Us, Inc. As of , FDA records show no recalls naming K190591.

Clearance record

Decision date
Received
(211 days to decision)
Product code
MUI Media, Coupling, Ultrasound
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Safersonic Us, Inc. 2873 Arlington Av, Suite 110, Highland Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code MUI

Trailing 12 months
2 clearances under product code MUI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MUI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260