Cleared Traditional

K082010 - STRYKER DISPOSABLE CRANIAL PERFORATOR BIT

K082010 is the FDA 510(k) clearance for STRYKER DISPOSABLE CRANIAL PERFORATOR BIT by Stryker Ireland Ltd., Instruments Division. It is a Class 2 Neurology device (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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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

Submission Details

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.

Device Classification

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 11
Devices cleared under the same product code (HBF) and FDA review panel - the closest regulatory comparables to K082010.
evoDrill Cranial Perforator
K231403 · Evonos GmbH & Co. KG · Mar 2024
NeuroLine Disposable Cranial Perforator with Hudson end
K213228 · Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. · Jun 2022
Codman Disposable Perforators
K183581 · Integra Lifesciences Corp. · Jan 2019
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