Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)
FDA 510(k) K250883 · Olympus Medical Systems Corporation
510(k) numberK250883
Submission
- Device name
- Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)
- Applicant
- Olympus Medical Systems Corporation
Hachioji-Shi, JP - Received
- March 24, 2025
- Decision date
- September 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
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| K260401 | Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)PSV · Traditional | 08/27/2026SE |
| K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)ODG · Traditional | 07/31/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | 07/01/2026SE |
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| K260580 | Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR); Clip (HX-610-090…PKL · Traditional | 05/21/2026SE |
| K252341 | Evis Exera III Bronchovideoscope (Olympus BF-Q190); Evis Exera III Bronchovideoscope…EOQ · Traditional | 04/23/2026SE |
| K252050 | Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241DEOB · Traditional | 03/20/2026SE |
Questions and answers
When was Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) cleared by the FDA?
Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) (K250883) received a 510(k) decision of Substantially Equivalent on September 18, 2025, 178 days after the submission was received.
What is the product code of K250883?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.