Cleared Special

K092729 - BAXANO NEURO CHECK DEVICE

K092729 is an FDA 510(k) clearance for BAXANO NEURO CHECK DEVICE, manufactured by Baxano, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Special 510(k) pathway after a 28-day FDA review.

K092729 · Baxano, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
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Oct 2009
Decision
28d
Days
Class 2
Risk

K092729 is an FDA 510(k) clearance for the BAXANO NEURO CHECK DEVICE. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Baxano, Inc. (Hillsborough, US). The FDA issued a Cleared decision on October 2, 2009 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. 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 Baxano, Inc. devices

FDA 510(k) Submission Details - K092729

510(k) Number K092729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2009
Decision Date October 02, 2009
Days to Decision 28 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
61d faster than avg
Panel avg: 89d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 43
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K092729.
STIMULATION/DISSECTION INSTRUMENTS
K112709 · Nu Vasive, Incorporated · Feb 2012
SEASPINE MONOPOLAR PROBE SYSYEM
K111671 · Seaspine, Inc. · Dec 2011
DISPOSABLE STIMULATING ELECTRODE
K111597 · Nuvasive, Inc. · Oct 2011
STIMULATING BUR GUARD
K063305 · Medtronic Xomed, Inc. · Nov 2006
XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238
K062549 · Excel Tech. , Ltd. · Oct 2006
NUVASIVE NEUROVISION JJB SYSTEM
K051718 · Nuvasive, Inc. · Sep 2005