HDE
H060002: IBV VALVE SYSTEM
FDA Humanitarian Device Exemption · Gyrus ACMI, Inc.
Key facts
| HDE number | H060002 |
|---|---|
| Trade name | IBV VALVE SYSTEM |
| Generic name | One-way air-leak valve |
| Applicant | Gyrus ACMI, Inc. |
| Owner/operator | OLYMPUS CORPORATION |
| Product code | OAZ |
| Approval date | Oct 24, 2008 |
| Docket number | 08M-O579 |
| Establishment registration | 3004450998 |
| FEI number | 3004450998 |
At a glance
- 10–99 Supplements
- May 26, 2026 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None 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: