FDA product code · Neurology · Class 2
GZL: Electrode, Depth
GZL is FDA's product code for "Electrode, Depth": a Class 2 device classified under 21 CFR 882.1330, reviewed by the Neurology panel.
510(k) review time for GZL
Across 16 510(k) clearances under GZL decided from 2018-01-01 to 2026-10-06, the median was 194 days from FDA receipt to decision. Half took between 86 and 243 days, and 80% were decided within 262 days. These are past clearances, not a forecast for a new submission.
| Fastest | 30 |
|---|---|
| 25th percentile | 86 |
| Median | 194 |
| 75th percentile | 243 |
| 80th percentile | 262 |
| 90th percentile | 373 |
| Slowest | 567 |
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.
GZL in the public FDA record
| 510(k) clearances, all years | 58 |
|---|---|
| Device recalls | 24 |
| GUDID device identifiers | 1,888 |
Counts of records, not of devices or events. Adverse event reports for GZL 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 GZL
No FDA recognized consensus standard cites GZL by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.