PSV

Ultrasound Bronchoscope

Product code: PSV
Device name: Ultrasound Bronchoscope
Device class: Class 2
21 CFR: 21 CFR 892.1550
Medical specialty: Radiology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 4

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).

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-08-27.

Number	Decision date	Applicant	Device name	Summary
K260401	2026-08-27	Olympus Medical Systems Corporation	EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS B	PDF

1 summaries are archived here for direct download.

Official FDA classification page: PSV

Classification and pathway per current FDA publications. Data from openFDA (CC0).