Cleared Traditional

K163565 - MR8 Drill System

K163565 is an FDA 510(k) clearance for MR8 Drill System, manufactured by Medtronic Powered Surgical Solutions. The device is a Class 2 Neurology device with product code HBC cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K163565 · Medtronic Powered Surgical Solutions · Neurology device
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Mar 2017
Decision
99d
Days
Class 2
Risk

K163565 is an FDA 510(k) clearance for the MR8 Drill System. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Medtronic Powered Surgical Solutions (Fort Worth, US). The FDA issued a Cleared decision on March 28, 2017 after a review of 99 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Powered Surgical Solutions devices

FDA 510(k) Submission Details - K163565

510(k) Number K163565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date March 28, 2017
Days to Decision 99 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 148d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBC Device Classification - Class 2, Special Controls

Product Code HBC Motor, Drill, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4360
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 - HBC Motor, Drill, Electric

All 17
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K163565.
hekaDrill
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K132264 · Nakanishi, Inc. · Dec 2013