Product code MUI
- Device name
- Media, Coupling, Ultrasound
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1570
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | 2026-04-24 |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | 2024-09-19 |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2024-07-24 |
| K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2022-08-30 |
| K211691 | Ultrast Gel | Ultrast, Inc. | 2021-12-22 |
| K190591 | Safergel Sterile Ultrasound Gel | Safersonic Us, Inc. | 2019-10-04 |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018-06-13 |
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 |
| K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 |
| K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. | 2017-10-25 |
| K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016-01-13 |
| K130581 | KONIX STERILE GEL | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2014-06-18 |
| K131905 | SOLID GEL PAD | Bluemtech | 2013-07-18 |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | Sheathing Technologies, Inc. | 2013-02-06 |
| K121311 | THIXO-GEL ULTRASOUND SPRAY | Cloverline International Pharma Services GmbH | 2012-08-30 |
| K112827 | SHEATHES ULTRASOND GEL | Sheathing Technologies, Inc. | 2012-06-22 |
| K102637 | DYNAREX ULTRASOUND GEL | Dynarex Corporation | 2011-02-16 |
| K102683 | THE ADDITION | Ob The-Addition, LLC | 2011-01-06 |
| K083358 | LUBRICANO-ULTRASOUND | Farco Pharma GmbH | 2009-01-09 |
| K072515 | EMBRACE GEL | Orison Corporation | 2007-09-20 |
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Sonotech, Inc. | 2004-11-05 |
| K033178 | ULTRABIO | Sonotech, Inc. | 2004-08-04 |
| K031018 | AUTOGEL PAD | Rich-Mar Corp. | 2003-12-08 |
| K031222 | SCANLUBE | Sonotech, Inc. | 2003-07-23 |
| K031894 | SCANTEC PAD | Sonotech, Inc. | 2003-07-18 |
| K030889 | ULTRAEKOGEL MODELS EK 2000 & EK 2001 | Inmed Ltda. | 2003-05-23 |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | Microtek Medical, Inc. | 2002-05-16 |
| K021132 | UNI-PATCH ULTRASOUND COUPLING GEL | The Ludlow Company LP | 2002-05-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344130252 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-04-09 |
| 10197344130269 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2026-01-23 |
| 10665973032662 | Dukal | Dukal LLC | 2026-01-12 |
| 10665973032631 | Dukal | Dukal LLC | 2026-01-12 |
| 10665973032648 | Dukal | Dukal LLC | 2026-01-12 |
| 10665973032655 | Dukal | Dukal LLC | 2026-01-12 |
| 10815112021433 | E-Z-GEL UltraSound Gel | Bracco Diagnostics Inc. | 2025-05-16 |
| 10815112021426 | E-Z-SCAN Low Viscosity UltraSound Gel | Bracco Diagnostics Inc. | 2025-05-16 |
| 10815112021419 | E-Z-SCAN Low Viscosity UltraSound Gel | Bracco Diagnostics Inc. | 2025-05-16 |
| 10815112021402 | E-Z-GEL UltraSound Gel | Bracco Diagnostics Inc. | 2025-05-16 |
| 10197106849064 | CARDINAL HEALTH | Cardinal Health 200, LLC | 2025-01-09 |
| 10080196306237 | Medline | MEDLINE INDUSTRIES, INC. | 2023-01-04 |
| 10193489025293 | Medline | MEDLINE INDUSTRIES, INC. | 2022-12-02 |
| 10842418100760 | SheathesGel | SHEATHING TECHNOLOGIES, INC. | 2017-08-22 |
| 10855683006064 | AQUASONIC | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006057 | AQUASONIC | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006040 | AQUASONIC | PARKER LABORATORIES INC | 2016-12-19 |
| 10855683006033 | AQUASONIC | PARKER LABORATORIES INC | 2016-12-19 |
| 10612479188454 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479188430 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479188416 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10612479188393 | McKesson | MCKESSON MEDICAL-SURGICAL INC. | 2016-12-09 |
| 10080196166251 | Medline | MEDLINE INDUSTRIES, INC. | 2016-10-14 |
| 10080196166299 | Medline | MEDLINE INDUSTRIES, INC. | 2016-09-27 |
| 10815112020566 | E-Z-GEL UltraSound Gel | Bracco Diagnostics Inc. | 2016-09-23 |
| 10815112020559 | E-Z-SCAN Low Viscosity UltraSound Gel | Bracco Diagnostics Inc. | 2016-09-23 |
| 10815112020542 | E-Z-SCAN Low Viscosity UltraSound Gel | Bracco Diagnostics Inc. | 2016-09-23 |
| 10815112020535 | E-Z-GEL UltraSound Gel | Bracco Diagnostics Inc. | 2016-09-23 |
| 10842418102030 | SheathesGel | SHEATHING TECHNOLOGIES, INC. | 2016-09-22 |
| 10842418102054 | SheathesGel | SHEATHING TECHNOLOGIES, INC. | 2016-09-22 |