Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)
FDA 510(k) K260401 · Olympus Medical Systems Corporation
Submission
- Device name
- Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F)
- Applicant
- Olympus Medical Systems Corporation
Hachioji-Shi, JP - Received
- February 6, 2026
- Decision date
- August 27, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PSV – Ultrasound Bronchoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1550
- Specialty
- Radiology
An ultrasound bronchoscope is indicated for the ultrasonic visualization, diagnosis and therapeutic access to the bronchial tree or the lungs. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code PSV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190FPSV · Traditional | Olympus Medical Systems Corp. | 09/06/2019SE |
| K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka Ssd-Alpha 5/10…PSV · Traditional | Olympus Medical Systems Corporation | 07/05/2007SE |
| K021204 | Olympus BF Type UM40PSV · Traditional | Olympus Optical Co., Ltd. | 05/01/2002SE |
More from Olympus Optical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K262079 | 4K Camera Head OLYMPUS CH-S700-08-LBFET · Traditional | 09/10/2026SE |
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · 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 |
| K251807 | Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LRKGE · Traditional | 03/06/2026SE |
Questions and answers
When was Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) cleared by the FDA?
Evis Eus Ultrasound Bronchofibervideoscope Olympus BF-UCP190F (BF-UCP190F) (K260401) received a 510(k) decision of Substantially Equivalent on August 27, 2026, 202 days after the submission was received.
What is the product code of K260401?
The FDA product code is PSV – Ultrasound Bronchoscope, a Class II (moderate risk) device regulated under 21 CFR 892.1550.