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Ultrasound Bronchoscope

FDA product code PSV · 4 cleared devices

Class 2 Radiology
Regulation
21 CFR 892.1550
Review panel
EN
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2002-05-01 – 2026-08-27

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).

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