Cleared Traditional

MR Compatible Aspiration Kit

K181731 · Mri Interventions, Inc. · Neurology

Nov 2018

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K181731 is an FDA 510(k) clearance for the MR Compatible Aspiration Kit, a Endoscope, Neurological (Class II — Special Controls, product code GWG), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on November 20, 2018, 144 days after receiving the submission on June 29, 2018. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1480.

Submission Details

510(k) Number	K181731 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 29, 2018
Decision Date	November 20, 2018
Days to Decision	144 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWG — Endoscope, Neurological
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1480
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).