Last synced on 2 December 2022 at 11:04 pm

Endoscope, Neurological

Page Type
Product Code
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).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1480
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1480 Neurological endoscope

§ 882.1480 Neurological endoscope.

(a) Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

(b) Classification. Class II (performance standards).

Endoscope, Neurological

Page Type
Product Code
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).
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.1480
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.1480 Neurological endoscope

§ 882.1480 Neurological endoscope.

(a) Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

(b) Classification. Class II (performance standards).