510(k) K260401
- Device
- EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)
- Applicant
- Olympus Medical Systems Corporation
- 510(k) number
- K260401
- Product code
- PSV
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-08-27
- Date received
- 2026-02-06
- Regulation
- 892.1550
- Classification name
- Ultrasound Bronchoscope
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Toshio Nakamura
- Address
- 2951 Ishikawa-Cho Hachioji-Shi JP 92-8507 92-8507
FDA Registration Numbers#
- 3008386005
- 8010047
- 3002808148
- 3042172882
- 3003637092
Source Documents#
Other 510(k) Records For Product Code PSV#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183525 | EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F | Olympus Medical Systems Corp. | 2019-09-06 |
| K070983 | OLYMPUS XBF-UC180F-DT8 ULTRASONIC BRONCHOFIBERVIDEOSCOPE USED WITH ALOKA SSD-ALPHA 5/10 ULTRASOUND SYSTEM | Olympus Medical Systems Corporation | 2007-07-05 |
| K021204 | OLYMPUS BF TYPE UM40 | Olympus Optical Co., Ltd. | 2002-05-01 |