Cleared Special

MRII Cranial Drill and Accessories

K160129 · Mri Interventions, Inc. · Neurology
Mar 2016
Decision
66d
Days
Class 2
Risk

About This 510(k) Submission

K160129 is an FDA 510(k) clearance for the MRII Cranial Drill and Accessories, 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 March 26, 2016, 66 days after receiving the submission on January 20, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K160129 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 2016
Decision Date March 26, 2016
Days to Decision 66 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HBG — Drills, Burrs, Trephines & Accessories (manual)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4300

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