FDA Product Code
FDA Product Code MUI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1570
510(k) Clearances — 34 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Foshan Pingchuang Medical Technology Co., Ltd. | 2026-06-17 | Traditional | PDF ↗ |
| K252337 | EdgeFlow Gel Pad | Edgecare, Inc. | 2026-04-24 | Traditional | PDF ↗ |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling Agent | Anhui Deepblue Medical Technology Co., Ltd. | 2024-09-19 | Traditional | PDF ↗ |
| K241789 | Non-Sterile Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2024-07-24 | Traditional | PDF ↗ |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | 2023-12-15 | Traditional | PDF ↗ |
| K221999 | Ultrasound Transmission Gels | Hony Medical Co., Ltd. | 2022-08-30 | Traditional | PDF ↗ |
| K211691 | Ultrast Gel | Ultrast, Inc. | 2021-12-22 | Traditional | PDF ↗ |
| K190591 | Safergel Sterile Ultrasound Gel | Safersonic Us, Inc. | 2019-10-04 | Traditional | PDF ↗ |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | H R Pharmaceuticals, Inc. | 2018-06-13 | Traditional | PDF ↗ |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 | Traditional | PDF ↗ |
| K163023 | Other-Sonic Transmission Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 | Traditional | PDF ↗ |
| K163024 | Ultra/Phonic Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-08 | Traditional | PDF ↗ |
| K163050 | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Advance Medical Designs, Inc. | 2017-10-25 | Traditional | PDF ↗ |
| K151070 | Sonishield 100 Antimicrobial Ultrasound Gel | Quotient Medical | 2016-01-13 | Traditional | PDF ↗ |
| K130581 | KONIX STERILE GEL | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | 2014-06-18 | Traditional | PDF ↗ |
| K131905 | SOLID GEL PAD | Bluemtech | 2013-07-18 | Traditional | PDF ↗ |
| K130041 | SHEATHES STERILE ULTRASOUND GEL | Sheathing Technologies, Inc. | 2013-02-06 | Traditional | PDF ↗ |
| K121311 | THIXO-GEL ULTRASOUND SPRAY | Cloverline International Pharma Services GmbH | 2012-08-30 | Traditional | PDF ↗ |
| K112827 | SHEATHES ULTRASOND GEL | Sheathing Technologies, Inc. | 2012-06-22 | Traditional | PDF ↗ |
| K102637 | DYNAREX ULTRASOUND GEL | Dynarex Corporation | 2011-02-16 | Traditional | PDF ↗ |
| K102683 | THE ADDITION | Ob The-Addition, LLC | 2011-01-06 | Traditional | PDF ↗ |
| K083358 | LUBRICANO-ULTRASOUND | Farco Pharma GmbH | 2009-01-09 | Traditional | PDF ↗ |
| K072515 | EMBRACE GEL | Orison Corporation | 2007-09-20 | Traditional | PDF ↗ |
| K042619 | ULTRABIO - IN VIVO BIOCOMPATIBLE, BIOELIMINATED STERILE ULTRASOUND IMAGING COUPLANT | Sonotech, Inc. | 2004-11-05 | Special | PDF ↗ |
| K033178 | ULTRABIO | Sonotech, Inc. | 2004-08-04 | Traditional | PDF ↗ |
| K031018 | AUTOGEL PAD | Rich-Mar Corp. | 2003-12-08 | Traditional | PDF ↗ |
| K031222 | SCANLUBE | Sonotech, Inc. | 2003-07-23 | Traditional | PDF ↗ |
| K031894 | SCANTEC PAD | Sonotech, Inc. | 2003-07-18 | Special | PDF ↗ |
| K030889 | ULTRAEKOGEL MODELS EK 2000 & EK 2001 | Inmed Ltda. | 2003-05-23 | Traditional | PDF ↗ |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | Microtek Medical, Inc. | 2002-05-16 | Traditional | PDF ↗ |
| K021132 | UNI-PATCH ULTRASOUND COUPLING GEL | The Ludlow Company LP | 2002-05-15 | Traditional | PDF ↗ |
| K013212 | WAVELENGHT ULTRASOUND LOTION | National Therapy Products, Inc. | 2002-02-25 | Traditional | PDF ↗ |
| K827296 | POLYSONIC ULTRASOUND LOTION | Parker Laboratories, Inc. | 1982-04-16 | Traditional | PDF ↗ |
Product code MUI · Class II · Radiology. Data: openFDA.