510(k) K052745

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 23, 2005

Date Received

September 30, 2005

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).