K202783 is an FDA 510(k) clearance for the Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing. This device is classified as a Negative Pressure Wound Therapy Powered Suction Pump (Class II - Special Controls, product code OMP).
Submitted by Smith & Nephew Medical Limited (Hull, GB). The FDA issued a Cleared decision on January 14, 2022, 479 days after receiving the submission on September 22, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780. For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts..
| 510(k) Number | K202783 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 22, 2020 |
| Decision Date | January 14, 2022 |
| Days to Decision | 479 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OMP — Negative Pressure Wound Therapy Powered Suction Pump |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4780 |
| Definition | For Wound Management Via Application Of Continual Or Intermittent Negative Pressure To The Wound For Removal Of Fluids, Including Wound Exudate, Irrigation Fluids, And Infectious Materials. The Device Is Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts. |