MUI · Media, Coupling, Ultrasound
Radiology · 21 CFR 892.1570 · Class 2
Overview
| Product Code | MUI |
|---|---|
| Device Name | Media, Coupling, Ultrasound |
| Regulation | 21 CFR 892.1570 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.
Classification Rationale
Class II.
Cleared Devices (32)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | Sep 19, 2024 | SESE |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | Jul 24, 2024 | SESE |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | Dec 15, 2023 | SESE |
| K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd. | Aug 30, 2022 | SESE |
| K211691 | Ultrast Gel | Ultrast, Inc. | Dec 22, 2021 | SESE |
| K190591 | Safergel Sterile Ultrasound Gel | Safersonic Us, Inc. | Oct 4, 2019 | SESE |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | Jun 13, 2018 | SESE |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | Jan 9, 2018 | SESE |
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | Jan 9, 2018 | SESE |
| K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | Jan 8, 2018 | SESE |
| K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | Jan 8, 2018 | SESE |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. | Oct 25, 2017 | SESE |
| K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | Jan 13, 2016 | SESE |
| K130581 | KONIX STERILE GEL | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | Jun 18, 2014 | SESE |
| K131905 | SOLID GEL PAD | Bluemtech | Jul 18, 2013 | SESE |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | Sheathing Technologies, Inc. | Feb 6, 2013 | SESE |
| K121311 | THIXO-GEL ULTRASOUND SPRAY | Cloverline International Pharma Services GmbH | Aug 30, 2012 | SESE |
| K112827 | SHEATHES ULTRASOND GEL | Sheathing Technologies, Inc. | Jun 22, 2012 | SESE |
| K102637 | DYNAREX ULTRASOUND GEL | Dynarex Corporation | Feb 16, 2011 | SESE |
| K102683 | THE ADDITION | Ob The-Addition, LLC | Jan 6, 2011 | SESE |
| K083358 | LUBRICANO-ULTRASOUND | Farco Pharma GmbH | Jan 9, 2009 | SESE |
| K072515 | EMBRACE GEL | Orison Corporation | Sep 20, 2007 | SESE |
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Sonotech, Inc. | Nov 5, 2004 | SESE |
| K033178 | ULTRABIO | Sonotech, Inc. | Aug 4, 2004 | SESE |
| K031018 | AUTOGEL PAD | Rich-Mar Corp. | Dec 8, 2003 | SESE |
| K031222 | SCANLUBE | Sonotech, Inc. | Jul 23, 2003 | SESE |
| K031894 | SCANTEC PAD | Sonotech, Inc. | Jul 18, 2003 | SESE |
| K030889 | ULTRAEKOGEL MODELS EK 2000 & EK 2001 | Inmed Ltda. | May 23, 2003 | SESE |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | Microtek Medical, Inc. | May 16, 2002 | SESE |
| K021132 | UNI-PATCH ULTRASOUND COUPLING GEL | The Ludlow Company LP | May 15, 2002 | SESE |
| K013212 | WAVELENGHT ULTRASOUND LOTION | National Therapy Products, Inc. | Feb 25, 2002 | SESE |
| K827296 | POLYSONIC ULTRASOUND LOTION | Parker Laboratories, Inc. | Apr 16, 1982 | SESE |
Top Applicants
- Sonotech, Inc. — 4 clearances
- Pharmaceutical Innovations, Inc. — 4 clearances
- Sheathing Technologies, Inc. — 2 clearances
- Hony Medical Co., Ltd. — 2 clearances
- Ultrast, Inc. — 1 clearance
