SmartGuide Disposable Guides and Grids
FDA 510(k) K260161 · UC-CARE , Ltd.
510(k) numberK260161
Submission
- Device name
- SmartGuide Disposable Guides and Grids
- Applicant
- UC-CARE , Ltd.
Yokneam, IL - Received
- January 20, 2026
- Decision date
- July 30, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K261170 | BA-004CCITX · Traditional | Fujifilm Corporation | 08/12/2026SE |
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| K100784 | Uc-Care Navigo SytemLLZ · Traditional | 11/01/2011SE |
| K090978 | Uc-Care Warming SystemGEH · Traditional | 08/10/2009SE |
Questions and answers
When was SmartGuide Disposable Guides and Grids cleared by the FDA?
SmartGuide Disposable Guides and Grids (K260161) received a 510(k) decision of Substantially Equivalent on July 30, 2026, 191 days after the submission was received.
What is the product code of K260161?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.