Dynarex Ultrasound Gel
FDA 510(k) K102637 · Dynarex Corporation
510(k) numberK102637
Submission
- Device name
- Dynarex Ultrasound Gel
- Applicant
- Dynarex Corporation
Orangeburg, NY, US - Received
- September 14, 2010
- Decision date
- February 16, 2011
- 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 |
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| K172266 | Dynarex Three-Way StopcockFMG · Traditional | 03/14/2018SE |
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| K151575 | Dynarex Eye CupsLXQ · Traditional | 09/01/2015SE |
| K103086 | Dynarex Intermittent Catheters, Male, Female, PediatricEZD · Traditional | 06/07/2011SE |
| K092488 | Dynarex Sterile Lubricating JellyKMJ · Traditional | 12/18/2009SE |
| K082863 | Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for…KNT · Traditional | 01/09/2009SE |
| K081569 | Dynarex/Tillotson Non-Sterile Powder Free Blue Nitrile Patient Exam Glove for Use with…LZA · Abbreviated | 09/12/2008SE |
| K052743 | Dynarex CPR Shield with One Way Valve and Barrier Filter, Model 4921CBP · Traditional | 12/22/2005SE |
| K052314 | Dynarex Vaginal Specula 4900, Models 4911-SMALL, 4912-MEDIUM, 4913-LARGEHIB · Traditional | 11/09/2005SE |
| K012816 | Dynarex Iodoform Packing Strips, Models 3411, 3412, 3413, 3414FRO · Traditional | 10/17/2002SE |
Questions and answers
When was Dynarex Ultrasound Gel cleared by the FDA?
Dynarex Ultrasound Gel (K102637) received a 510(k) decision of Substantially Equivalent on February 16, 2011, 155 days after the submission was received.
What is the product code of K102637?
The FDA product code is MUI – Media, Coupling, Ultrasound, a Class II (moderate risk) device regulated under 21 CFR 892.1570.