EOX

30 FDA 510(k) clearances · Product code

FDA profile

Official device name

Esophagoscope (Flexible Or Rigid)

Device class

Class II (moderate risk)

Regulation

21 CFR 874.4710

Medical specialty

Ear, Nose, Throat

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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