OUJ

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Product code

OUJ

Device name

High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist

Device class

Class 2

21 CFR

21 CFR 892.1570

Medical specialty

Radiology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

2

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

4 (all years; only the last 3 years are listed here)

FDA classification definition

To provide high level disinfection of ultrasound transducers. 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 (2)

Last three years. Most recent: 2025-08-05.

2 summaries are archived here for direct download.