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510(k) K181731

MR Compatible Aspiration Kit by Mri Interventions, Inc. — Product Code GWG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2018
Date Received
June 29, 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).

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