PSVClass II

Ultrasound Bronchoscope

21 CFR 892.1550 / Radiology

PSV is the FDA product code for Ultrasound Bronchoscope, a class II device type, regulated under 21 CFR 892.1550. FDA's definition for this code 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 for this device type must be included in a 510(k) submission (82 FR 26807...". As of 2026-09-10, FDA records hold 4 510(k) clearances under this code, the most recent dated 2026-08-27, and 2 recalls.

Classification record

Product code: PSV
Device name: Ultrasound Bronchoscope
FDA 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).
Regulation: 21 CFR 892.1550
Device class: Class II
Review panel: Radiology
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 4
Ingested recalls: 2

Clearances, product code PSV

By decision year

4 clearances under product code PSV with a decision year between 2002 and 2026, 2002 the highest year at 1.

Show the numbers

510(k) clearances under FDA product code PSV by decision year
Year	Clearances
2002	1
2007	1
2019	1
2026	1

Applicants with the most clearances

Product code PSV

Applicants holding the most 510(k) clearances under product code PSV
Applicant	Clearances
Olympus Medical Systems Corp.	2
Olympus Medical Systems Corporation	1
Olympus Optical Co., Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code