Cleared Traditional

MRII CRAINIAL DRILL

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

About This 510(k) Submission

K122456 is an FDA 510(k) clearance for the MRII CRAINIAL DRILL, 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 review panel. Regulated under 21 CFR 882.4300.

Submission Details

510(k) Number K122456 FDA.gov
FDA Decision Cleared 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

Similar Devices — HBG Drills, Burrs, Trephines & Accessories (manual)

All 16
LEGACY
K252696 · Phasor Health, LLC · Nov 2025
Taps for Resorbable Screws
K153587 · Synthes USA Products, LLC · Jan 2017
SpineGuard DSG Zavation Screw System
K162884 · Spineguard S.A. · Jan 2017
MRII Cranial Drill and Accessories
K160129 · Mri Interventions, Inc. · Mar 2016
SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mm
K151536 · Mri Interventions, Inc. · Jul 2015
HAND DRILL, MODEL 11-9901-7
K022712 · Medical Design, LLC · Nov 2002