Data / Medical devices / Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (QFC): 6 FDA-registered makers in 4 countries
6 establishments in 4 countries are registered with the FDA to make Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (product code QFC, Class 2, 21 CFR 878.4783). 6 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 3 510(k) clearances under this code, the latest on February 13, 2023, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QFC
- Device class
- 2
- Regulation
- 878.4783
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| Costa Rica | 1 |
| Ireland | 1 |
| United Kingdom | 1 |
Makers of Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arthrocare Corporation | Coyol Alajuela, Costa Rica | Manufacturer | 1 | December 14, 2021 | 0 | 0 | 0 | api.fda.gov |
| KCI Manufacturing | Athlone - Co. Westmeath, Ireland | Manufacturer | 1 | February 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| KCI NORTH IX (Technical Services Center) | San Antonio, TX, United States | Manufacturer | 1 | February 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Complaint file establishment, Specification developer | 1 | February 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Kci Usa, Inc. | San Antonio, TX, United States | Manufacturer | 1 | February 13, 2023 | 0 | 1 | 0 | api.fda.gov |
| Smith & Nephew Medical Ltd | HULL East Riding of Yorkshire, United Kingdom | Specification developer | 1 | December 14, 2021 | 0 | 0 | 0 | api.fda.gov |
Updated February 13, 2023. 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.