FDA device listing
PLUME-AWAY,PLUME AWAY - 4.0,ULTRA PLUME AWAY - 6.0
FDA device listing 1203773991 · STRYKER CORP.
Key facts
| Proprietary names | PLUME-AWAY,PLUME AWAY - 4.0,ULTRA PLUME AWAY - 6.0 |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Product codes | FCZ |
| Device names | FCZ - Tube, Smoke Removal, Endoscopic |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.1500 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | STRYKER ENDOSCOPY |
| Establishment registrations | 2936485 |
| FEI numbers | 2936485 |
| Establishment operations | Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database