FDA product code · Neurology · Class 2
GXH: Device, Surgical, Cryogenic
GXH is FDA's product code for "Device, Surgical, Cryogenic": a Class 2 device classified under 21 CFR 882.4250, reviewed by the Neurology panel.
510(k) review time for GXH
Across 10 510(k) clearances under GXH decided from 2018-01-01 to 2026-10-06, the median was 56 days from FDA receipt to decision. Half took between 29 and 78 days, and 80% were decided within 89 days. These are past clearances, not a forecast for a new submission.
| Fastest | 29 |
|---|---|
| 25th percentile | 29 |
| Median | 56 |
| 75th percentile | 78 |
| 80th percentile | 89 |
| 90th percentile | 145 |
| Slowest | 281 |
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.
FDA-recognized standards that cite GXH
No FDA recognized consensus standard cites GXH 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.