Cleared Traditional

K063305 - STIMULATING BUR GUARD

K063305 is an FDA 510(k) clearance for STIMULATING BUR GUARD, manufactured by Medtronic Xomed, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K063305 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Nov 2006
Decision
28d
Days
Class 2
Risk

K063305 is an FDA 510(k) clearance for the STIMULATING BUR GUARD. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 29, 2006 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Xomed, Inc. devices

FDA 510(k) Submission Details - K063305

510(k) Number K063305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2006
Decision Date November 29, 2006
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 - ETN Stimulator, Nerve

All 41
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K063305.
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NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005
CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE
K050162 · Medtronic Xomed, Inc. · Mar 2005