510(k) · Cleared
ClearedModel 3875 1 X 8 SC Test Stimulation Lead
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
Cleared on Aug 16, 2006 after a 28-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 16, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- GZB
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Medtronic Model 3873 1 x 8 Test Stimulation Lead Named without a submission number | |
| * | — | Medtronic Model 3874 1 x 8 Compact Test Stimulation Lead Named without a submission number |
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 Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following: * Failed Back Syndrome or Low Back Syndrome or Failed Back; * Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome; * Post Laminectomy Pain; * Unsuccessful Disk Surgery; * Degenerative Disk Disease (DDD/ Herniated pain refractory to…
Read the full statement (134 words)
The Model 3875 1 x 8 SC Test Stimulation Lead is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:
* Failed Back Syndrome or Low Back Syndrome or Failed Back;
* Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome;
* Post Laminectomy Pain;
* Unsuccessful Disk Surgery;
* Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
* Peripheral Causalgia;
* Epidural Fibrosis;
* Arachnoiditis or Lumbar Adhesive Arachnoiditis;
* Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and,
* Multiple Back Surgeries
Additional Contraindication: The Medtronic Model 3875 1 x 8 SC Test Stimulation Lead is contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062041: Model 3875 1 X 8 SC Test Stimulation Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062041
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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