Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
FDA 510(k) K042619 · Sonotech, Inc.
510(k) numberK042619
Submission
- Device name
- Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant
- Applicant
- Sonotech, Inc.
Bellingham, WA, US - Received
- September 24, 2004
- Decision date
- November 5, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
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|---|---|---|---|
| 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 |
| K190591 | Safergel Sterile Ultrasound GelMUI · Traditional | Safersonic Us, Inc. | 10/04/2019SE |
| 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 |
More from Pharmaceutical Innovations, Inc.
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|---|---|---|
| K033178 | UltrabioMUI · Traditional | 08/04/2004SE |
| K031222 | ScanlubeMUI · Traditional | 07/23/2003SE |
| K031894 | Scantec PadMUI · Special | 07/18/2003SE |
| K013701 | Endo-GlideGCJ · Traditional | 02/04/2002SE |
| K013170 | Scantac Membrane or Scantac StripITX · Traditional | 11/13/2001SE |
| K984562 | VivosonicITX · Traditional | 06/08/1999SE |
| K983691 | Scanflex Solid Couplant MembraneITX · Traditional | 05/05/1999SE |
| K983985 | Hybrisonic SheathITX · Traditional | 02/25/1999SE |
| K981028 | Ultra Image and Ultra ScanITX · Traditional | 08/21/1998SE |
| K964658 | OasisITX · Traditional | 02/14/1997SE |
Questions and answers
When was Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant cleared by the FDA?
Ultrabio - in Vivo Biocompatible, Bioeliminated Sterile Ultrasound Imaging Couplant (K042619) received a 510(k) decision of Substantially Equivalent on November 5, 2004, 42 days after the submission was received.
What is the product code of K042619?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.