Cleared Traditional

K122456 - MRII CRAINIAL DRILL (FDA 510(k) Clearance)

K122456 · Mri Interventions, Inc. · Neurology device
Mar 2013
Decision
221d
Days
Class 2
Risk

K122456 is an FDA 510(k) clearance for the MRII CRAINIAL DRILL. This device is classified as 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 22, 2013, 221 days after receiving the submission on August 13, 2012.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K122456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2012
Decision Date March 22, 2013
Days to Decision 221 days
Submission Type Traditional
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