510(k) K163023
- Device
- Other-Sonic Transmission Gel
- Applicant
- PHARMACEUTICAL INNOVATIONS, INC.
- 510(k) number
- K163023
- Product code
- MUI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-01-08
- Date received
- 2016-10-31
- Regulation
- 892.1570
- Classification name
- Media, Coupling, Ultrasound
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SHIRLEY J. BERGMAN
- Address
- 897 Frelinghuysen Ave. Newark NJ US 07114 07114
FDA Registration Numbers#
- 9616874
- 9710018
- 2950776
- 2435946
- 3008502431
- 3012316249
- 3016447251
- 1649518
- 2011171
- 1061124
- 1417592
- 3011767724
- 3016761372
- 1037885
- 3008177921
- 1030451
- 3006636956
- 1423537
- 2212018
- 3003623887
- 9616088
- 3009482034
- 3009437400
- 3013595964
- 3007143236
- 9710388
- 3008751375
Source Documents#
Other 510(k) Records For Product Code MUI #
| 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 |
| K232957 | Sterile and Non-Sterile Ultrasound Gels | Jianerkang Medical Co., Ltd. | 2023-12-15 |
| 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 |
| K163027 | Ultra/Phonic Free Conductivity Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 |
| K163026 | Ultra/Phonic Scanning Gel | Pharmaceutical Innovations, Inc. | 2018-01-09 |
| 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 |
Legacy Summary#
summary
FDA Review#
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