Product code KTI

Device name

Bronchoscope Accessory

Medical specialty

Ear, Nose, Throat

Device class

2

Regulation number

874.4680

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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).

Source

FDA openFDA device classification dataset