510(k) · Cleared
ClearedModification to Axxess Spinal Cord Stimulation Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Neuromodulation Systems · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Mar 28, 2003 after a 24-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 28, 2003
- Review
- 24 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GZB? 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 GZB device
- #1 K221376 Nalu Neurostimulation Systemscore 8.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All GZB devicesGZB Stimulator, Spinal-Cord, Implanted (Pain Relief): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZB
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · GZB
149in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZB
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZB
313in 2025
MAUDE reports naming product code GZB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 201 |
| 2008 | 1 | — | 1 | 68 |
| 2009 | 3 | 62 | 0 | 59 |
| 2010 | 1 | — | 1 | 157 |
| 2011 | 4 | 67 | 0 | 471 |
| 2012 | 2 | — | 0 | 1,090 |
| 2013 | 2 | — | 0 | 4,428 |
| 2014 | 2 | — | 0 | 10,849 |
| 2015 | 2 | — | 0 | 7,507 |
| 2016 | 2 | — | 0 | 4,556 |
| 2017 | 2 | — | 0 | 5,511 |
| 2018 | 1 | — | 0 | 5,244 |
| 2019 | 4 | 149 | 0 | 643 |
| 2020 | 2 | — | 0 | 466 |
| 2021 | 1 | — | 0 | 332 |
| 2022 | 1 | — | 0 | 209 |
| 2023 | 0 | — | 0 | 236 |
| 2024 | 1 | — | 0 | 318 |
| 2025 | 0 | — | 0 | 313 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The AXXESSTM Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities. The AXXESSTM lead system is designed to be used with the following devices: • MedtronicB MattrixB Model 3272 RF system receiver and compatible transmitter, or • MedtronicB X-TRELB Model 3470 RF system receiver and compatible transmitter using the MedtronicB Model 7495…
Read the full statement (115 words)
The AXXESSTM Lead is designed to be utilized as the lead component of a spinal cord stimulation system and is used to aid in the management of chronic pain of the trunk and/or extremities.
The AXXESSTM lead system is designed to be used with the following devices:
• MedtronicB MattrixB Model 3272 RF system receiver and compatible transmitter, or
• MedtronicB X-TRELB Model 3470 RF system receiver and compatible transmitter using the MedtronicB Model 7495 Quadripolar extension, and
• MedtronicB Model 3550-05 Percutaneous Extension with the MedtronicB Model 3550-03 Screener cable, and
• The MedtronicB Model 3628 DualScreenTMScreener using Axxess Screener Cable or
• The ANS TS-8 or MNT90TRR-16 Test Stimulator using Axxess Screener Cable.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030674 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030674: Modification to Axxess Spinal Cord Stimulation Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030674
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026