Cleared Traditional

K081742 - BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25

K081742 is an FDA 510(k) clearance for BAXANO NEURAL LOCALIZATION PROBE 1.75 A..., manufactured by Baxano, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K081742 · Baxano, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
90d
Days
Class 2
Risk

K081742 is an FDA 510(k) clearance for the BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Baxano, Inc. (Mountain View, US). The FDA issued a Cleared decision on September 17, 2008 after a review of 90 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K081742

510(k) Number K081742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2008
Decision Date September 17, 2008
Days to Decision 90 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
At panel average
Panel avg: 90d · This submission: 90d
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 84
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K081742.
BAXANO NEURO CHECK DEVICE
K092729 · Baxano, Inc. · Oct 2009
NEUROSIGN AVALANCHE MOTOR NERVE MONITOR
K083242 · The Magstim Company , Ltd. · Jul 2009
STIMULUS/DISSECTION INSTRUMENTS
K090838 · Axon Systems, Inc. · Jul 2009
RHYTHMLINK INTERNATIONAL MONOPOLAR STIMULATING INSTRUMENT
K072736 · Rhythmlink International, LLC · Jan 2008
NEUROSIGN LARYNGEAL ELECTRODES
K071349 · The Magstim Company , Ltd. · Dec 2007
HILGER DUAL-STIM NERVE STIMULATOR
K063560 · Wr Medical Electronics Co. · Jan 2007