DEN180013 is an FDA 510(k) submission for the PREVENA 125 and PREVENA PLUS 125 Therapy Units. 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 Kci USA, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on April 19, 2019.
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 | DEN180013 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | March 15, 2018 |
| Decision Date | April 19, 2019 |
| Days to Decision | 400 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | — |
| 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. |