DeviceClearance

Product code PSV— Radiology

EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F (BF-UCP190F)

Classification name
Ultrasound Bronchoscope
Device class
Class 2
Regulation
21 CFR 892.1550
Advisory panel
Radiology
Total cleared
4
First cleared
Most recent

FDA classification definition

“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).”

— U.S. Food and Drug Administration, device classification record for product code PSV under 21 CFR 892.1550, via openFDA

Market context for product code PSV

FDA has cleared 4 devices under product code PSV between 2002 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PSV

Adverse events under product code PSV

product code PSV
Death
6
Injury
305
Malfunction
3,705
Total
4,016

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PSV

Data sourced from openFDA. This site is unofficial and independent of the FDA.