K122132 is an FDA 510(k) clearance for the AVANCE FOAM DRESSING KIT INCL. TRANSPARENT FILM, TRANSFER PAD (SMALL, MEDIUM, LARGE) AVANCE TRANSPARENT FILM AVANCE FOAM, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Molnlycke Health Care (Norcross, US). The FDA issued a Cleared decision on January 17, 2013, 183 days after receiving the submission on July 18, 2012. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K122132 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 18, 2012 |
| Decision Date | January 17, 2013 |
| Days to Decision | 183 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. |