FDA product code · Neurology · Class 2
HCG: Device, Neurovascular Embolization
HCG is FDA's product code for "Device, Neurovascular Embolization": a Class 2 device classified under 21 CFR 882.5950, reviewed by the Neurology panel. FDA flags it as an implant.
510(k) review time for HCG
Across 28 510(k) clearances under HCG decided from 2018-01-01 to 2026-10-06, the median was 105 days from FDA receipt to decision. Half took between 29 and 161 days, and 80% were decided within 192 days. These are past clearances, not a forecast for a new submission.
| Fastest | 23 |
|---|---|
| 25th percentile | 29 |
| Median | 105 |
| 75th percentile | 161 |
| 80th percentile | 192 |
| 90th percentile | 264 |
| 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.
HCG in the public FDA record
| 510(k) clearances, all years | 187 |
|---|---|
| Device recalls | 68 |
| Establishment listings | 373 |
| GUDID device identifiers | 5,385 |
Counts of records, not of devices or events. Adverse event reports for HCG 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 HCG
No FDA recognized consensus standard cites HCG 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.