K203369 is an FDA 510(k) clearance for the Avance Solo Negative Pressure Wound Therapy (NPWT) System, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Molnlycke Health Care Us, LLC (Peachtree Corners, US). The FDA issued a Cleared decision on July 1, 2021, 227 days after receiving the submission on November 16, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K203369 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 16, 2020 |
| Decision Date | July 01, 2021 |
| Days to Decision | 227 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. |