IntelliCartTM System
FDA 510(k) K190789 · Dornoch Medical Systems
510(k) numberK190789
Submission
- Device name
- IntelliCartTM System
- Applicant
- Dornoch Medical Systems
Riverside, MO, US - Received
- March 27, 2019
- Decision date
- April 24, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01)JCX · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 05/11/2026SE |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | Microvention | 06/13/2025SE |
| K251111 | CaryJCX · Traditional | Excitus AS | 05/07/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/02/2024SE |
| K233428 | Easycess Aspiration PumpJCX · Traditional | Guangzhou Easycess Medical Co.,Ltd | 11/03/2023SE |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional | Stryker Instruments | 12/09/2022SE |
| K182950 | Acare Suction UnitJCX · Traditional | Acare Technology Co., Ltd. | 08/23/2019SE |
| K190105 | ZOOM Aspiration PumpJCX · Special | Taiwan Biomaterial Co., Ltd. | 02/21/2019SE |
| K180115 | TWBM PumpJCX · Traditional | Taiwan Biomaterial Co., Ltd. | 07/24/2018SE |
| K181398 | DV-300 AspiratorJCX · Traditional | Ding Hwa Co., Ltd. | 07/23/2018SE |
More from Ding Hwa Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172481 | IntelliCart SystemJCX · Special | 09/14/2017SE |
| K162421 | IntelliCartTM SystemJCX · Special | 12/21/2016SE |
| K133786 | Dornoch Duo Suction Cart with: DL2800 Lid, CL500 Lid, Dornoch Quad Suction Cart with:…JCX · Traditional | 03/21/2014SE |
| K123188 | Dornoch Duo Suction Cart with DL2800 Lid Model UL-DU2800, Dornoch Duo Suction Cart with…JCX · Special | 03/04/2013SE |
| K081047 | Transposal Ultra SystemsJCX · Traditional | 04/29/2008SE |
Questions and answers
When was IntelliCartTM System cleared by the FDA?
IntelliCartTM System (K190789) received a 510(k) decision of Substantially Equivalent on April 24, 2019, 28 days after the submission was received.
What is the product code of K190789?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.