Safergel Sterile Ultrasound Gel
FDA 510(k) K190591 · Safersonic Us, Inc.
510(k) numberK190591
Submission
- Device name
- Safergel Sterile Ultrasound Gel
- Applicant
- Safersonic Us, Inc.
Highland Park, IL, US - Received
- March 7, 2019
- Decision date
- October 4, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code MUI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253255 | Non-Sterile Ultrasound Gel Sterile Ultrasound GelMUI · Traditional | Foshan Pingchuang Medical Technology Co., Ltd. | 06/17/2026SE |
| K252337 | EdgeFlow Gel PadMUI · Traditional | Edgecare, Inc. | 04/24/2026SE |
| K242167 | Sterile and Non-Sterile Ultrasonic Coupling AgentMUI · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 09/19/2024SE |
| K241789 | Non-Sterile Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 07/24/2024SE |
| K232957 | Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | Jianerkang Medical Co., Ltd. | 12/15/2023SE |
| K221999 | Ultrasound Transmission GelsMUI · Traditional | Hony Medical Co., Ltd. | 08/30/2022SE |
| K211691 | Ultrast GelMUI · Traditional | Ultrast, Inc. | 12/22/2021SE |
| K181363 | EcoVue Sterile and Non-Sterile Ultrasound GelsMUI · Traditional | H R Pharmaceuticals, Inc. | 06/13/2018SE |
| K163027 | Ultra/Phonic Free Conductivity GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/09/2018SE |
| K163026 | Ultra/Phonic Scanning GelMUI · Traditional | Pharmaceutical Innovations, Inc. | 01/09/2018SE |
Questions and answers
When was Safergel Sterile Ultrasound Gel cleared by the FDA?
Safergel Sterile Ultrasound Gel (K190591) received a 510(k) decision of Substantially Equivalent on October 4, 2019, 211 days after the submission was received.
What is the product code of K190591?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.