FDA device listing
VOLISTA,VOLISTA ACCESS,VOLISTA ACCESS II,VOLISTA STANDOP,VOLISTA STANDOP II
FDA device listing 1442948379 · Getinge AB
Key facts
| Proprietary names | VOLISTA,VOLISTA ACCESS,VOLISTA ACCESS II,VOLISTA STANDOP,VOLISTA STANDOP II |
|---|---|
| Owner/operator | Getinge AB |
| Owner/operator number | 10090886 |
| Premarket submissions | K130513 |
| Product codes | FSY, FTD |
| Device names | FSY - Light, Surgical, Ceiling Mounted, FTD - Lamp, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4580 |
| Review panels | General & Plastic Surgery |
| Registered establishments | GETINGE AB |
| Establishment registrations | 3031563141 |
| FEI numbers | 3031563141 |
| Establishment operations | Complaint File Establishment |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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