Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
FDA 510(k) K231666 · FUJIFILM Healthcare Americas Corporation
510(k) numberK231666
Submission
- Device name
- Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)
- Applicant
- FUJIFILM Healthcare Americas Corporation
Lexington, MA, US - Received
- June 7, 2023
- Decision date
- December 13, 2023
- 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 |
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| K233583 | FCT iSTREAM Phase 1JAK · Traditional | 04/26/2024SE |
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| K231941 | ARIETTA x10IYN · Traditional | 11/20/2023SE |
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Questions and answers
When was Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) cleared by the FDA?
Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) (K231666) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 189 days after the submission was received.
What is the product code of K231666?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.