Cleared Special

SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm

K151536 · Mri Interventions, Inc. · Neurology

Jul 2015

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K151536 is an FDA 510(k) clearance for the SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm, a Drills, Burrs, Trephines & Accessories (manual) (Class II — Special Controls, product code HBG), submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on July 8, 2015, 30 days after receiving the submission on June 8, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number	K151536 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2015
Decision Date	July 08, 2015
Days to Decision	30 days
Submission Type	Special
Review Panel	Neurology (NE)
Summary	Summary PDF