Sheathes Ultrasond Gel
FDA 510(k) K112827 · Sheathing Technologies, Inc.
510(k) numberK112827
Submission
- Device name
- Sheathes Ultrasond Gel
- Applicant
- Sheathing Technologies, Inc.
Morgan Hill, CA, US - Received
- September 28, 2011
- Decision date
- June 22, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K153212 | Sheathes Ultrasound Probe CoversITX · Traditional | 03/04/2016SE |
| K130041 | Sheathes Sterile Ultrasound GelMUI · Traditional | 02/06/2013SE |
| K100966 | Colonoscope/Sigmoidoscope SheathesFDF · Traditional | 08/03/2010SE |
| K091828 | Sheathesiso Ultrasound Transducer CoverITX · Traditional | 09/28/2009SE |
| K043425 | Sheathes Needle Guide, Model NG-SR-A-484-KIT (There Will Be Various Model Numbers Based…ITX · Traditional | 02/28/2005SE |
| K990175 | Sheathes (Non-Latex), SterileITX · Traditional | 04/21/1999SE |
Questions and answers
When was Sheathes Ultrasond Gel cleared by the FDA?
Sheathes Ultrasond Gel (K112827) received a 510(k) decision of Substantially Equivalent on June 22, 2012, 268 days after the submission was received.
What is the product code of K112827?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.