Arthur
FDA 510(k) K260190 · ROPCA ApS
510(k) numberK260190
Submission
- Device name
- Arthur
- Applicant
- ROPCA ApS
Odense M, DK - Received
- January 22, 2026
- Decision date
- June 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Sonic Incytes Medical Corp
| 510(k) | Device | Decision |
|---|---|---|
| K260192 | DianaQIH · Traditional | 07/24/2026SE |
Questions and answers
When was Arthur cleared by the FDA?
Arthur (K260190) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 147 days after the submission was received.
What is the product code of K260190?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.