Cleared Traditional

K022712 - HAND DRILL, MODEL 11-9901-7

K022712 is an FDA 510(k) clearance for HAND DRILL, manufactured by Medical Design, LLC. The device is a Class 2 Neurology device with product code HBG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K022712 · Medical Design, LLC · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
90d
Days
Class 2
Risk

K022712 is an FDA 510(k) clearance for the HAND DRILL, MODEL 11-9901-7. Classified as Drills, Burrs, Trephines & Accessories (manual) (product code HBG), Class II - Special Controls.

Submitted by Medical Design, LLC (Brandon, US). The FDA issued a Cleared decision on November 12, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4300 - 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.

FDA 510(k) Submission Details - K022712

510(k) Number K022712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2002
Decision Date November 12, 2002
Days to Decision 90 days
Submission Type Traditional
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
59d faster than avg
Panel avg: 149d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 14
Devices cleared under the same product code (HBG) and FDA review panel - the closest regulatory comparables to K022712.
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
MRII CRAINIAL DRILL
K122456 · Mri Interventions, Inc. · Mar 2013
FRAMELOCK
K022370 · Medtronic Xomed, Inc. · Oct 2002
CNS INTERCHANGEABLE BIT CRANIAL DRILL
K961113 · Clinical Neuro Systems, LLC · Jun 1996
MODIFICATION TO GHAJAR GUIDE TWIST DRILL
K932402 · Neurodynamics, Inc. · Aug 1993
K022712 · HAND DRILL, MODEL 11-9901-7
Download PDF FDA Summary Medical Design, LLC