Cleared Special

K160129 - MRII Cranial Drill and Accessories

K160129 is an FDA 510(k) clearance for MRII Cranial Drill and Accessories, manufactured by Mri Interventions, Inc.. The device is a Class 2 Neurology device with product code HBG cleared through the Special 510(k) pathway after a 66-day FDA review.

K160129 · Mri Interventions, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
66d
Days
Class 2
Risk

K160129 is an FDA 510(k) clearance for the MRII Cranial Drill and Accessories. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Mri Interventions, Inc. (Irvine, US). The FDA issued a Cleared decision on March 26, 2016 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K160129

510(k) Number K160129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 149d · This submission: 66d
Pathway characteristics
Modification to existing cleared device.

HBG Device Classification - Class 2, Special Controls

Product Code HBG Drills, Burrs, Trephines & Accessories (manual)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HBG Drills, Burrs, Trephines & Accessories (manual)

All 16
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K160129.
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K160129 · MRII Cranial Drill and Accessories
Download PDF FDA Summary Mri Interventions, In…