Cleared Special

K031003 - STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K031003 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Apr 2003
Decision
11d
Days
Class 2
Risk

K031003 is an FDA 510(k) clearance for the STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES. 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 April 11, 2003 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K031003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date April 11, 2003
Days to Decision 11 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 89d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 96
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K031003.
Evala Nerve Stimulator (EPNR002)
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