Product code GWG

Device name

Endoscope, Neurological

Medical specialty

Neurology

Device class

2

Regulation number

882.1480

Review panel

NE

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