510(k) K223263 ยท QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Prevena Plus 125 Therapy Unit
| Applicant | 3M, San Antionio TX, US |
| Decision | Substantially Equivalent, Feb 13, 2023 |
| Received | Oct 24, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2025 | KCI USA, INC. 3M Prevena Plus 125 Therapy Unit and System Kits
REF:
PRE3021US Prevena Plus Duo Peel and Place 20cm System Kit, US
PRE3201US Prevena Plus Peel and Place 35 cm system Kit, US
PRE3201 Prevena Plus Open, Classified |
QFC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.