MUI — Media, Coupling, Ultrasound Class II
FDA product code MUI covers "Media, Coupling, Ultrasound", a Class II medical device regulated under 21 CFR 892.1570. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MUI
- Device Class
- Class II
- Regulation Number
- 892.1570
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253255 | Foshan Pingchuang Medical Technology Co | Non-Sterile Ultrasound Gel Sterile Ultrasound Gel | Jun 17, 2026 |
| K252337 | Edgecare | EdgeFlow Gel Pad | Apr 24, 2026 |
| K242167 | Anhui Deepblue Medical Technology Co | Sterile and Non-Sterile Ultrasonic Coupling Agent | Sep 19, 2024 |
| K241789 | Hony Medical Co | Non-Sterile Ultrasound Transmission Gels | Jul 24, 2024 |
| K232957 | Jianerkang Medical Co | Sterile and Non-Sterile Ultrasound Gels | Dec 15, 2023 |
| K221999 | Hony Medical Co | Ultrasound Transmission Gels | Aug 30, 2022 |
| K211691 | Ultrast | Ultrast Gel | Dec 22, 2021 |
| K190591 | Safersonic Us | Safergel Sterile Ultrasound Gel | Oct 4, 2019 |
| K181363 | H R Pharmaceuticals | EcoVue Sterile and Non-Sterile Ultrasound Gels | Jun 13, 2018 |
| K163026 | Pharmaceutical Innovations | Ultra/Phonic Scanning Gel | Jan 9, 2018 |
| K163027 | Pharmaceutical Innovations | Ultra/Phonic Free Conductivity Gel | Jan 9, 2018 |
| K163023 | Pharmaceutical Innovations | Other-Sonic Transmission Gel | Jan 8, 2018 |
| K163024 | Pharmaceutical Innovations | Ultra/Phonic Conductivity Gel | Jan 8, 2018 |
| K163050 | Advance Medical Designs | Advance Medical Designs, Inc. Sterile Ultrasound Gel | Oct 25, 2017 |
| K151070 | Quotient Medical | Sonishield 100 Antimicrobial Ultrasound Gel | Jan 13, 2016 |
| K130581 | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasa | KONIX STERILE GEL | Jun 18, 2014 |
| K131905 | Bluemtech | SOLID GEL PAD | Jul 18, 2013 |
| K130041 | Sheathing Technologies | SHEATHES STERILE ULTRASOUND GEL | Feb 6, 2013 |
| K121311 | Cloverline International Pharma Services | THIXO-GEL ULTRASOUND SPRAY | Aug 30, 2012 |
| K112827 | Sheathing Technologies | SHEATHES ULTRASOND GEL | Jun 22, 2012 |