Data / Medical devices / United States / Gyrus ACMI, Inc.
Gyrus ACMI, Inc.: FDA-registered device maker in Redmond, WA, United States, 1 PMA approval
Gyrus ACMI, Inc. is registered with the FDA (registration 3004450998) in Redmond, WA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated December 3, 2018. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004450998
- Address
- 6675 185th Avenue NE, Redmond, WA, United States, 98052
- Owner or operator
- OLYMPUS CORPORATION (9067818)
- Roles
- Manufacturer
- First device listed
- August 23, 2010
- Registered through
- 2027
- Brand names listed
- IBV Valve, IBV Valve System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| One-Way Air-Leak Valve | OAZ | f | Manufacturer | accessdata.fda.gov |
| Valve, Pulmonary | NJK | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| December 3, 2018 | P180007 | Spiration® Valve System | NJK | 11 | August 20, 2026 | accessdata.fda.gov |
Compare with other makers
Updated August 20, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.