510(k) · Cleared
ClearedWide Spaced Quattrode Leads
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 Oct 11, 2007 after a 41-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Oct 11, 2007
- Review
- 41 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK072462 Wide Spaced Quattrode LeadsAdvanced Neuromodulation Systems · 2007
- Descendant · cites it directly · 0 of its ownK123299 MTS System, Wide-Space Quattrode Percutaneous LeadsSt. Jude Medical Neuromodulation · 2013 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K123299MTS System, Wide-Space Quattrode Percutaneous LeadsSt. Jude Medical Neuromodulation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072462 | Wide Spaced Quattrode Leads | Advanced Neuromodulation Systems | 2007 | — |
| +1 | K123299 | MTS System, Wide-Space Quattrode Percutaneous Leads | St. Jude Medical Neuromodulation | 2013 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123299 | MTS System, Wide-Space Quattrode Percutaneous Leads | 2013 | 0 |
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?
- Of its descendants, K123299 (St. Jude Medical Neuromodulation, 2013) has gone furthest, with 0 descendants of its own.
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. 2007, this device’s year, is highlighted.
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 ANS Neurostimulation Systems are indicated for spinal cord stimulation
(SCS) in the treatment of chronic pain of the trunk and limbs, either as the
sole mitigating agent, or as an adjunct to other modes of therapy used in a
multidisciplinary approach. ANS Percutaneous Leads model number 3066,
3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341,
3342, 3343, and receiver model number 3408, transmitter model number
3508, and antenna model numbers 1220 and 1230 are also indicated to
stimulate electrically peripheral nerves to relieve severe intractable pain.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K072462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072462: Wide Spaced Quattrode Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072462
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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