Cleared Traditional

K080052 - STRYKER ESSX WITH NAVIGATION MOUNT

K080052 is the FDA 510(k) clearance for STRYKER ESSX WITH NAVIGATION MOUNT by Stryker Corp.. It is a Class 2 Ear, Nose, Throat device (product code ERL) cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K080052 · Stryker Corp. · Ear, Nose, Throat device
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Oct 2008
Decision
268d
Days
Class 2
Risk

K080052 is an FDA 510(k) clearance for the STRYKER ESSX WITH NAVIGATION MOUNT. Classified as Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (product code ERL), Class II - Special Controls.

Submitted by Stryker Corp. (Kalamazoo, US). The FDA issued a Cleared decision on October 2, 2008 after a review of 268 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 Corp. devices

Submission Details

510(k) Number K080052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 2008
Decision Date October 02, 2008
Days to Decision 268 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
179d slower than avg
Panel avg: 89d · This submission: 268d
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 54
Devices cleared under the same product code (ERL) and FDA review panel - the closest regulatory comparables to K080052.
DTAD
K121678 · Gyrus Acmi, Inc. · Aug 2012
STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
K112593 · Stryker Corporation · May 2012
REPROCESSED ENT SHAVERS
K081814 · Sterilmed, Inc. · Dec 2008
PRIMADO SURGICAL DRILL
K080722 · Nakanishi, Inc. · Sep 2008
XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)
K081277 · Medtronic Xomed, Inc. · Sep 2008
XPS 3000 SYSTEM
K073255 · Medtronic Xomed, Inc. · Mar 2008