FDA product code GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZB is the FDA product code for stimulator, spinal-cord, implanted (pain relief). It is a Class II device, regulated under 21 CFR 882.5880 and reviewed by the Neurology panel. FDA has cleared 139 510(k) submissions under GZB, 2 in the last five years, from 23 different applicants. The average 510(k) review took 117 days (median 87); 268 days on average over the last three years. FDA has posted 5 recalls for GZB devices.
Classification
| Field | Value |
|---|---|
| Device name | Stimulator, Spinal-Cord, Implanted (Pain Relief) |
| Device class | Class II |
| Regulation | 21 CFR 882.5880 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for GZB
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 84 |
| 2018 | 1 | 159 |
| 2019 | 4 | 142 |
| 2020 | 2 | 60 |
| 2021 | 1 | 111 |
| 2022 | 1 | 29 |
| 2024 | 1 | 268 |
Compare with all 510(k) review times · Search every GZB clearance
Top GZB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medtronic Vascular | 56 | 2004-03-25 |
| Advanced Neuromodulation Systems | 24 | 2009-12-23 |
| Neuromed, Inc. | 15 | 1996-05-22 |
| Stimwave Technologies Incorporated | 8 | 2019-03-29 |
| Boston Scientific Neuromodulation | 7 | 2024-08-23 |
18 more applicants have GZB clearances. See the full list in Caduvo.
Most recent GZB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233801 | Boston Scientific Neuromodulation | Nalu Neurostimulation System for Spinal Cord Stimulation; Nalu Neurostimulation System for Peripheral Nerve Stimulation | 2024-08-23 | 268 |
| K221376 | Boston Scientific Neuromodulation | Nalu Neurostimulation System | 2022-06-10 | 29 |
| K203547 | Boston Scientific Neuromodulation | Nalu Neurostimulation System | 2021-03-25 | 111 |
| K202274 | Boston Scientific Neuromodulation | Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits | 2020-11-09 | 90 |
| K201618 | Boston Scientific Neuromodulation | Nalu Neurostimulation SCS system | 2020-07-15 | 30 |
Recalls for GZB devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-07-29.
Frequently asked questions
What is FDA product code GZB?
GZB is the FDA product code for stimulator, spinal-cord, implanted (pain relief). It is a Class II device, regulated under 21 CFR 882.5880 and reviewed by the Neurology panel.
What device class is GZB?
Class II, regulation 21 CFR 882.5880. Typical premarket route: 510(k).
How long does a 510(k) take for product code GZB?
Across 139 cleared submissions the average was 117 days from receipt to decision (median 87).
Which companies have the most GZB clearances?
Medtronic Vascular (56); Advanced Neuromodulation Systems (24); Neuromed, Inc. (15); Stimwave Technologies Incorporated (8); Boston Scientific Neuromodulation (7).
Have GZB devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2014-07-29.
Next steps
- Run an FDA pathway report with predicate devices for product code GZB
- Run a recall and safety report across every GZB manufacturer
- Watch product code GZB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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