EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F
K183525 is the FDA 510(k) clearance record for EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F, a class II device, cleared for Olympus Medical Systems Corp. on under FDA product code PSV (Ultrasound Bronchoscope). FDA's definition for product code PSV reads: "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...". FDA records list 186 510(k) clearances for Olympus Medical Systems Corp., from to . As of , FDA records show one recall naming K183525.
Clearance record
- Decision date
- Received
- (261 days to decision)
- Product code
- PSV Ultrasound Bronchoscope
- Regulation
- 21 CFR 892.1550
- Device class
- Class II
- Review panel
- Radiology
- Applicant
- Olympus Medical Systems Corp. 2951 Ishikawa-Cho, Hachioji-Shi, JP
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code PSV
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 1 |
| September 2026 | 0 |
| October 2026 | 0 |
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