Ultra/Phonic Free Conductivity Gel

FDA 510(k) K163027 · Pharmaceutical Innovations, Inc.

Substantially Equivalent

510(k) numberK163027

Submission

Device name
Ultra/Phonic Free Conductivity Gel
Applicant
Pharmaceutical Innovations, Inc.
Newark, NJ, US
Received
October 31, 2016
Decision date
January 9, 2018
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

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K242167Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional Anhui Deepblue Medical Technology Co., Ltd.09/19/2024SE
K241789Non-Sterile Ultrasound Transmission GelsMUI · Traditional Hony Medical Co., Ltd.07/24/2024SE
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
K163026Ultra/Phonic Scanning GelMUI · Traditional Pharmaceutical Innovations, Inc.01/09/2018SE

More from Pharmaceutical Innovations, Inc.

510(k)DeviceDecision
K163026Ultra/Phonic Scanning GelMUI · Traditional 01/09/2018SE
K163024Ultra/Phonic Conductivity GelMUI · Traditional 01/08/2018SE
K163023Other-Sonic Transmission GelMUI · Traditional 01/08/2018SE
K961222Evron GelKMJ · Traditional 06/26/1996SE

Questions and answers

When was Ultra/Phonic Free Conductivity Gel cleared by the FDA?

Ultra/Phonic Free Conductivity Gel (K163027) received a 510(k) decision of Substantially Equivalent on January 9, 2018, 435 days after the submission was received.

What is the product code of K163027?

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