Cleared Traditional

K032303 - STRYKER CONSOLIDATED OPERATING ROOM EQU...

K032303 is the FDA 510(k) clearance for STRYKER CONSOLIDATED OPERATING ROOM EQU... by Stryker Instruments. It is a Class 2 Neurology device (product code HBE) cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K032303 · Stryker Instruments · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
175d
Days
Class 2
Risk

K032303 is an FDA 510(k) clearance for the STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM. Classified as Drills, Burrs, Trephines & Accessories (simple, Powered) (product code HBE), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 175 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4310 - 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 Instruments devices

Submission Details

510(k) Number K032303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2003
Decision Date January 16, 2004
Days to Decision 175 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
27d slower than avg
Panel avg: 148d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBE Drills, Burrs, Trephines & Accessories (simple, Powered)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4310
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 - HBE Drills, Burrs, Trephines & Accessories (simple, Powered)

All 40
Devices cleared under the same product code (HBE) and FDA review panel - the closest regulatory comparables to K032303.
ANSPACH COUPLER
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ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM
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ANSPACH ADVANCED MICRO SAW ATTACHMENTS
K040076 · The Anspach Effort, Inc. · Mar 2004
CRANIOCUT
K022942 · Aesculap, Inc. · Oct 2002
ANSPACH ANGLED MICRONOSE ATTACHMENT
K002903 · The Anspach Effort, Inc. · Oct 2000
75K STAIGHT DRILL
K943541 · Stryker Corp. · May 1995