FDA product code · Neurology · Class 2
GZB: Stimulator, Spinal-Cord, Implanted (Pain Relief)
GZB is FDA's product code for "Stimulator, Spinal-Cord, Implanted (Pain Relief)": a Class 2 device classified under 21 CFR 882.5880, reviewed by the Neurology panel. FDA flags it as an implant.
510(k) review time for GZB
Across 10 510(k) clearances under GZB decided from 2018-01-01 to 2026-10-06, the median was 126 days from FDA receipt to decision. Half took between 90 and 159 days, and 80% were decided within 164 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 90 |
| Median | 126 |
| 75th percentile | 159 |
| 80th percentile | 164 |
| 90th percentile | 191 |
| Slowest | 268 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
GZB in the public FDA record
| 510(k) clearances, all years | 139 |
|---|---|
| Establishment listings | 116 |
| GUDID device identifiers | 408 |
Counts of records, not of devices or events. Adverse event reports for GZB are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite GZB
2 FDA recognized consensus standards cite GZB, among them ISO 14708-3 Second edition 2017-04; ASTM F3333-20. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 17-15 ISO 14708-3 Second edition 2017-04 — Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators
- 8-558 ASTM F3333-20 — Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.