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Baxano Neural Localization Probe 1.75 And 1.25

by Baxano, Inc.

510(k) K081742

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK081742 Date17 Sep 2008ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ETN
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Baxano Neural Localization Probe is a nerve stimulator designed for the localization of motor nerves. It is intended for use in conjunction with Baxano cutting and biting devices in clinical settings where visual identification of nerves is required.

This device is classified as a Class 2 nerve stimulator under regulation 874.1820 and is authorized via the FDA 510(k) process. It is available in 1.75 and 1.25 sizes.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of the Baxano Neural Localization Probe?

    This device is a nerve stimulator specifically designed to assist in the localization of motor nerves during clinical procedures where visual identification of nerves is required.

  • How is the probe intended to be used in a clinical setting?

    The probe is designed to be used in conjunction with Baxano cutting and biting devices to help clinicians safely identify motor nerves during surgical interventions.

  • What sizes are available for this device?

    The Baxano Neural Localization Probe is available in two specific sizes: 1.75 and 1.25.

  • What is the regulatory classification of this nerve stimulator?

    The device is classified as a Class 2 nerve stimulator under regulation 874.1820 and was authorized for use via the FDA 510(k) process.