JEJ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Tubing, Instrumentation, Bronchoscope (Brush Sheath A/O Aspirating)

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4680

Medical specialty

Ear, Nose, Throat

Flags

Third-party review eligible

FDA definition

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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