510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K151070Substantially Equivalent

Sonishield 100 Antimicrobial Ultrasound Gel

Quotient Medical, Burlington, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151070 is the FDA 510(k) clearance record for Sonishield 100 Antimicrobial Ultrasound Gel, a class II device, cleared for Quotient Medical on under FDA product code MUI (Media, Coupling, Ultrasound). FDA records list one 510(k) clearance for Quotient Medical. As of , FDA records show no recalls naming K151070.

Clearance record

Decision date
Received
(267 days to decision)
Product code
MUI Media, Coupling, Ultrasound
Regulation
21 CFR 892.1570
Device class
Class II
Review panel
Radiology
Applicant
Quotient Medical 3365 Harvester Rd., Suite 110, Burlington, CA
510(k) summary
Summary PDF
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