Non-Sterile Ultrasound Transmission Gels

FDA 510(k) K241789 · Hony Medical Co., Ltd.

Substantially Equivalent

510(k) numberK241789

Submission

Device name
Non-Sterile Ultrasound Transmission Gels
Applicant
Hony Medical Co., Ltd.
Taishan, CN
Received
June 21, 2024
Decision date
July 24, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MUI – Media, Coupling, Ultrasound
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1570
Specialty
Radiology

Other 510(k)s with product code MUI

510(k)DeviceApplicantDecision
K253255Non-Sterile Ultrasound Gel Sterile Ultrasound GelMUI · Traditional Foshan Pingchuang Medical Technology Co., Ltd.06/17/2026SE
K252337EdgeFlow Gel PadMUI · Traditional Edgecare, Inc.04/24/2026SE
K242167Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional Anhui Deepblue Medical Technology Co., Ltd.09/19/2024SE
K232957Sterile and Non-Sterile Ultrasound GelsMUI · Traditional Jianerkang Medical Co., Ltd.12/15/2023SE
K221999Ultrasound Transmission GelsMUI · Traditional Hony Medical Co., Ltd.08/30/2022SE
K211691Ultrast GelMUI · Traditional Ultrast, Inc.12/22/2021SE
K190591Safergel Sterile Ultrasound GelMUI · Traditional Safersonic Us, Inc.10/04/2019SE
K181363EcoVue Sterile and Non-Sterile Ultrasound GelsMUI · Traditional H R Pharmaceuticals, Inc.06/13/2018SE
K163027Ultra/Phonic Free Conductivity GelMUI · Traditional Pharmaceutical Innovations, Inc.01/09/2018SE
K163026Ultra/Phonic Scanning GelMUI · Traditional Pharmaceutical Innovations, Inc.01/09/2018SE

More from Pharmaceutical Innovations, Inc.

510(k)DeviceDecision
K241615Transducer Probe CoverITX · Special 07/03/2024SE
K221278Transducer Probe CoverITX · Traditional 01/11/2023SE
K221999Ultrasound Transmission GelsMUI · Traditional 08/30/2022SE

Questions and answers

When was Non-Sterile Ultrasound Transmission Gels cleared by the FDA?

Non-Sterile Ultrasound Transmission Gels (K241789) received a 510(k) decision of Substantially Equivalent on July 24, 2024, 33 days after the submission was received.

What is the product code of K241789?

The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.