K223263 is an FDA 510(k) clearance for the Prevena Plus 125 Therapy Unit. This device is classified as a Negative Pressure Wound Therapy Device For Reduction Of Wound Complications (Class II - Special Controls, product code QFC).
Submitted by 3M (San Antionio, US). The FDA issued a Cleared decision on February 13, 2023, 112 days after receiving the submission on October 24, 2022.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4783. A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds..
| 510(k) Number | K223263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2022 |
| Decision Date | February 13, 2023 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QFC - Negative Pressure Wound Therapy Device For Reduction Of Wound Complications |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4783 |
| Definition | A Negative Pressure Wound Therapy Device For Reduction Of Wound Complications Is A Powered Suction Pump Intended For Wound Management And Reduction Of Wound Complications Via Application Of Negative Pressure To The Wound, Which Removes Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. This Device Type Is Intended For Use With Wound Dressings Classified Under 21 Cfr 878.4780. This Classification Does Not Include Devices Intended For Organ Space Wounds. |