Cleared Traditional

K082010 - STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

K082010 is an FDA 510(k) clearance for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT, manufactured by Stryker Ireland Ltd., Instruments Division. The device is a Class 2 Neurology device with product code HBF cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K082010 · Stryker Ireland Ltd., Instruments Division · Neurology device
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Optimized for regulatory review, auditing and printing
Dec 2008
Decision
167d
Days
Class 2
Risk

K082010 is an FDA 510(k) clearance for the STRYKER DISPOSABLE CRANIAL PERFORATOR BIT. Classified as Drills, Burrs, Trephines & Accessories (compound, Powered) (product code HBF), Class II - Special Controls.

Submitted by Stryker Ireland Ltd., Instruments Division (Carrigtwohill, Co.Cork, IE). The FDA issued a Cleared decision on December 29, 2008 after a review of 167 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4305 - 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 Stryker Ireland Ltd., Instruments Division devices

FDA 510(k) Submission Details - K082010

510(k) Number K082010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2008
Decision Date December 29, 2008
Days to Decision 167 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
19d slower than avg
Panel avg: 148d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBF Device Classification - Class 2, Special Controls

Product Code HBF Drills, Burrs, Trephines & Accessories (compound, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4305
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 - HBF Drills, Burrs, Trephines & Accessories (compound, Powered)

All 13
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K082010.
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
EASYDRILL AUTOSTOP CRANIAL PERFORATOR
K141455 · Micromar Ind. Com. , Ltd. · Mar 2015
MERIDIAN CRANIAL PERFORATOR
K121253 · Adeor Medical Technologies GmbH · Jul 2012
CRANIAL PERFORATOR
K082637 · The Anspach Effort, Inc. · Dec 2008
CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231
K073336 · Codman & Shurtleff, Inc. · Jan 2008
CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223
K071931 · Codman & Shurtleff, Inc. · Oct 2007