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510(k) K151070

Sonishield 100 Antimicrobial Ultrasound Gel by Quotient Medical — Product Code MUI

K151070 is an FDA 510(k) premarket notification submitted by Quotient Medical for the device "Sonishield 100 Antimicrobial Ultrasound Gel". The FDA issued a decision of Substantially Equivalent on January 13, 2016. The device falls under product code MUI (Media, Coupling, Ultrasound), a Class II device regulated under 21 CFR 892.1570.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2016
Date Received
April 21, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Coupling, Ultrasound
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

Other clearances for product code MUI

  • K253255 — Non-Sterile Ultrasound Gel Sterile Ultrasound Gel (June 17, 2026)
  • K252337 — EdgeFlow Gel Pad (April 24, 2026)
  • K242167 — Sterile and Non-Sterile Ultrasonic Coupling Agent (September 19, 2024)
  • K241789 — Non-Sterile Ultrasound Transmission Gels (July 24, 2024)
  • K232957 — Sterile and Non-Sterile Ultrasound Gels (December 15, 2023)
  • K221999 — Ultrasound Transmission Gels (August 30, 2022)
  • K211691 — Ultrast Gel (December 22, 2021)
  • K190591 — Safergel Sterile Ultrasound Gel (October 4, 2019)
  • K181363 — EcoVue Sterile and Non-Sterile Ultrasound Gels (June 13, 2018)
  • K163026 — Ultra/Phonic Scanning Gel (January 9, 2018)

FDA data resources