510(k) Report

510(k) · Cleared

Cleared

Disposable Monopolar and Bipolar Stimulator Probes

K062996510(k) TraditionalCleared Jan 12, 2007102-day reviewClass II21 CFR 882.1350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Axon Systems, Inc. · GXZ Electrode, Needle

Cleared on Jan 12, 2007 as substantially equivalent to K050325 (Technomed Europe, 2005) and 1 other predicate after a 102-day review. Its family tree reaches back 3 generations to 1992. 32 later devices descend from it.

Decided
Jan 12, 2007
Review
102 days
Class
Class II
Product code
GXZ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K923056 (1992). 6 ancestors in all. 32 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1999: 1 other ancestor1998: 1 other ancestor1997: 1 other ancestor2011: 4 descendants cleared2007: 1 descendant cleared2012: 3 descendants cleared2009: 1 descendant cleared2010: 1 descendant cleared2008: 1 descendant cleared2015: 1 descendant cleared2014: 5 descendants cleared2018: 2 descendants cleared2023: 4 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2016: 1 descendant cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 2 descendants clearedK923056 · Neurosign Model 100 · The Magstim Company, Ltd. · 1992 · recalledK991583 · Neurosign 400, 4 Channel Motor Nerve Monitor · The Magstim Company, Ltd. · 1999K050325 · Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe · Technomed Europe · 20051990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 10 descendants3 generations forward: 9 descendants4 generations forward: 4 descendants5 generations forward: 2 descendants K050325 · Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe · Technomed Europe · 2005K991583 · Neurosign 400, 4 Channel Motor Nerve Monitor · The Magstim Company, Ltd. · 1999K923056 · Neurosign Model 100 · The Magstim Company, Ltd. · 1992 · recalled0+5
  1. Root · 3 generations backK923056 Neurosign Model 100The Magstim Company, Ltd. · 1992 · Recalled
  2. 2 generations backK991583 Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd. · 1999
  3. 1 generation backK050325 Disposable Concentric Probe, Disposable Bipolar Probe, Disposable…Technomed Europe · 2005
  4. This deviceK062996 Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc. · 2007
  5. Descendant · cites it directly · 19 of its ownK090838 Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
  6. Descendant · cites it directly · 19 of its ownK063729 Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007
  7. Descendant · cites it directly · 17 of its ownK103128 Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip…Cadwell Lab, Inc. · 2011
  8. Descendant · 2 generations on · 10 of its ownK111597 Disposable Stimulating ElectrodeNuvasive, Inc. · 2011
  9. Descendant · 3 generations on · 9 of its ownK112709 Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12009: 12010: 12011: 42012: 32014: 52015: 12016: 12018: 22019: 22022: 22023: 42024: 12025: 12026: 2
2007high 5 (2014) · low 0 (2013)2026

Most influential descendants

Showing 5 of 32 · See all
  • K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009 · cites it directly19descendants
  • K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe · 2007 · cites it directly19descendants
  • K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc. · 2011 · cites it directly17descendants
  • K111597Disposable Stimulating ElectrodeNuvasive, Inc. · 2011 · 2 generations on10descendants
  • K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated · 2012 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K923056Neurosign Model 100The Magstim Company, Ltd.19921
−2K991583Neurosign 400, 4 Channel Motor Nerve MonitorThe Magstim Company, Ltd.1999—
−1K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar…Technomed Europe2005—
0 (this device)K062996Disposable Monopolar and Bipolar Stimulator ProbesAxon Systems, Inc.2007—
+1K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.2009—
+1K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe2007—
+1K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip…Cadwell Lab, Inc.2011—
+2K111597Disposable Stimulating ElectrodeNuvasive, Inc.2011—
+3K112709Stimulation/Dissection InstrumentsNu Vasive, Incorporated2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200910
201010
201140
201230
201450
201510
201610
201820
201920
202220
202340
202410
202510
202620
FIG. 1 — Lineage of K062996, 1992–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GXZ device

  1. #1 K231691 Phantom XL Insulated Dilatorsscore 10.4 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K050325Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe
Summary page 1
…d Throat; 874.1820 Neurology; 882.1350 Procodes: ETN, GXZ Predicate Technomed Europe - Disposable Probes (K050325) Devices: Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869)…
Technomed Europe2005—
*K992869Xomed Ball-Tip Monopolar Stimulator Probe
Summary page 1
…te Technomed Europe - Disposable Probes (K050325) Devices: Xomed Surgical Products - Ball Tip Monopolar stimulating probe (K992869) / /4Z. Summary: Descriptio…
Xomed, Inc.1999—

Also cleared against K050325: 3 other devices →

What descends from it? (32)

See all 32

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090838Stimulus/Dissection InstrumentsAxon Systems, Inc.200919
K063729Disposable Pedicle Screw Probe, Model 3603-00Technomed Europe200719
K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw…Cadwell Lab, Inc.201117
K110419Avs Aria Neuromonitoring Probe and Avs Aria Probe DilatorsStryker Spine20119
K100992NeuralmasInnovative Surgical Solutions, LLC ("Iss")20106
K073229Nerve Monitoring CablePioneer Surgical Technology20085
K112426Xian Friendship Disposable Nerve Stimulator ProbesXian Friendship Medical Electronics Co., Ltd.20122

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K090838 (Axon Systems, Inc., 2009) has gone furthest, with 19 descendants of its own.
  • 3 other devices also cite its predicate K050325.

How does its category compare?

All GXZ devices

GXZ Electrode, Needle: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · GXZ

1in 2024

2007: 32008: 22010: 12011: 22012: 12013: 22014: 22016: 12019: 22020: 12023: 22024: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXZ

102in 2007

2007: 102 days median
2007high 102 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXZ

1in 2021

2010: 192021: 1
2007high 19 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXZ

75in 2025

2007: 22009: 22010: 42011: 42012: 122013: 62014: 82015: 122016: 112017: 62018: 92019: 142020: 72021: 92022: 182023: 212024: 582025: 75
2007high 75 (2025) · low 0 (2008)2025

MAUDE reports naming product code GXZ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007310202
20082—00
20090—02
20101—194
20112—04
20121—012
20132—06
20142—08
20150—012
20161—011
20170—06
20180—09
20192—014
20201—07
20210—19
20220—018
20232—021
20241—058
20250—075
20260—0—

What is it indicated for?

To locate, identify and monitor cranial motor nerves, peripheral nerves and spinal nerve roots during surgery.

Indications for use as stated in the FDA summary.

Also cleared against K050325

3 other devices cite the same predicate.

  • K130136Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes,Technomed Europe · 20132 recalls
  • K103128Cadwell Disposable Monopolar / Bipolar / Concentric / Flush Tip /Ball Tip Pedicle Screw Stimulator Probe,Cadwell Lab, Inc. · 2011
  • K100912Disposable Nerve Stimulating Probe, Bipolar Concentric, Disposable Nerve Stimulator Probe, Bipolar Side by…Kirwan Surgical Products, Inc. · 2010

More from Axon Systems, Inc.

15 FDA decisions under this applicant name. See the company

  • K090838Stimulus/Dissection InstrumentsAxon Systems, Inc. · 2009
  • K062198Sunspots Pre-Gelled Surface ElectrodesAxon Systems, Inc. · 2006
  • K061639Eclipse TCD Neurovascular Workstation; Elclipse Neurological Workstation with TCD and Vascular Doppler…Axon Systems, Inc. · 2006
  • K061113OrthomonAxon Systems, Inc. · 2006
  • K050798Eclipse Neurological WorkstationAxon Systems, Inc. · 2005

Recent decisions in GXZ

The GXZ category page

  • K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe · 2024
  • K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. · 2023
  • K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. · 2023
  • K200984Guardian Needle ElectrodeRhythmlink International, LLC · 2020
  • K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl · 2019

https://510kreport.com/device/K062996 · printed Nov 4, 2026

Cite this page

510(k) Report. “K062996: Disposable Monopolar and Bipolar Stimulator Probes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062996

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026