Disposable Intraoperative Probe (DIOP8)
FDA 510(k) K201425 · Huntleigh Healthcare Limited
510(k) numberK201425
Submission
- Device name
- Disposable Intraoperative Probe (DIOP8)
- Applicant
- Huntleigh Healthcare Limited
Cardiff, GB - Received
- May 29, 2020
- Decision date
- February 19, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K250524 | Mendaera Guidance SystemITX · Traditional | Mendaera, Inc. | 07/02/2025SE |
| K250469 | Accuro® 3S Needle Guide KitITX · Traditional | Rivanna Medical, Inc. | 06/13/2025SE |
| K241662 | Ultrasound Transducer CoverITX · Traditional | Vitrolife Sweden AB | 08/30/2024SE |
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| K132650 | Sonicaid Freedom Wireless Fetal Monitoring SystemHGM · Traditional | 02/07/2014SE |
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Questions and answers
When was Disposable Intraoperative Probe (DIOP8) cleared by the FDA?
Disposable Intraoperative Probe (DIOP8) (K201425) received a 510(k) decision of Substantially Equivalent on February 19, 2021, 266 days after the submission was received.
What is the product code of K201425?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.