Cleared Traditional

K112593 - STYKER CONSOLIDATED OPERATING ROOM EQUI...

K112593 is the FDA 510(k) clearance for STYKER CONSOLIDATED OPERATING ROOM EQUI... by Stryker Corporation. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K112593 · Stryker Corporation · Ear, Nose, Throat device
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May 2012
Decision
237d
Days
Class 2
Risk

K112593 is an FDA 510(k) clearance for the STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Corporation (Kalamazoo, US). The FDA issued a Cleared decision on May 1, 2012 after a review of 237 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4250 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Corporation devices

Submission Details

510(k) Number K112593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2011
Decision Date May 01, 2012
Days to Decision 237 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 89d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4250
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ERL Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece

All 45
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K112593.
STRYKER S2 DRILL
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DTAD
K121678 · Gyrus Acmi, Inc. · Aug 2012
REPROCESSED ENT SHAVERS
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KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES
K053262 · KARL STORZ Endoscopy-America, Inc. · Dec 2005