510(k) K182211

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

January 18, 2019

Date Received

August 15, 2018

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Endoscope, Neurological

Device Class

Class II

Regulation Number

882.1480

Review Panel

NE

Submission Type

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).