FDA device listing
PICO 14 Single Use Negative Pressure Wound Therapy System,PICO 7 Single Use Negative Pressure Wound Therapy System,PICO…
FDA device listing 1088354115 · SMITH AND NEPHEW MEDICAL LTD.
Key facts
| Proprietary names | PICO 14 Single Use Negative Pressure Wound Therapy System,PICO 7 Single Use Negative Pressure Wound Therapy System,PICO 7Y Single Use Negative Pressure Wound Therapy System |
|---|---|
| Owner/operator | SMITH AND NEPHEW MEDICAL LTD. |
| Owner/operator number | 9001952 |
| Premarket submissions | K203716 |
| Product codes | QFC |
| Device names | QFC - Negative Pressure Wound Therapy Device For Reduction Of Wound Complications |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4783 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Smith & Nephew Medical Ltd |
| Establishment registrations | 8043484 |
| FEI numbers | 3002808194 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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