Cleared Special

K060260 - MICROPOWER HAND PIECE HIGH SPEED DRILL

K060260 is an FDA 510(k) clearance for MICROPOWER HAND PIECE HIGH SPEED DRILL, manufactured by Linvatec Corp.. The device is a Class 2 Neurology device with product code HBC cleared through the Special 510(k) pathway after a 68-day FDA review.

K060260 · Linvatec Corp. · Neurology device
Download Printable Device Report (PDF)
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Apr 2006
Decision
68d
Days
Class 2
Risk

K060260 is an FDA 510(k) clearance for the MICROPOWER HAND PIECE HIGH SPEED DRILL. Classified as Motor, Drill, Electric (product code HBC), Class II - Special Controls.

Submitted by Linvatec Corp. (Largo, US). The FDA issued a Cleared decision on April 10, 2006 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4360 - 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.

View all Linvatec Corp. devices

FDA 510(k) Submission Details - K060260

510(k) Number K060260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date April 10, 2006
Days to Decision 68 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
80d faster than avg
Panel avg: 148d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 21
Devices cleared under the same product code (HBC) and FDA review panel - the closest regulatory comparables to K060260.
D4000 DRIVE SYSTEM
K130497 · Linvatec Corporation D/B/A Conmed Linvatec · Mar 2013
PRIMADO
K083112 · Nakanishi, Inc. · Apr 2009
CONMED LINVATEC OSPREY DRILL SYSTEM
K080444 · Conmed Linvatec · Apr 2008
MICROSPEED UNI MOTOR SYSTEM
K053526 · Aesculap, Inc. · Jan 2006
THE BIOPLATE BATTERY POWERED DRILL
K022986 · Bioplate, Inc. · Nov 2002
ANSPACH EMAX DRILL SYSTEM
K011444 · The Anspach Effort, Inc. · Aug 2001