HDE
H020002: NEUROFORM MICRODELIVERY STENT
FDA Humanitarian Device Exemption · Stryker Neurovascular
Key facts
| HDE number | H020002 |
|---|---|
| Trade name | NEUROFORM MICRODELIVERY STENT |
| Generic name | Intracranial neurovascular stent |
| Applicant | Stryker Neurovascular |
| Owner/operator | STRYKER CORP. |
| Product code | NJE |
| Approval date | Sep 11, 2002 |
| Docket number | O2M-0409 |
| Establishment registration | 3008853977 |
| FEI number | 3008853977 |
At a glance
- 10–99 Supplements
- Jun 26, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1,000+ MAUDE adverse event reports
- 1–9 Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: