K050261 is an FDA 510(k) clearance for the V.A.C. GRANUFOAM SILVER PROTECTION DRESSING, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Kinetic Concepts, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 26, 2005, 111 days after receiving the submission on February 4, 2005. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K050261 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 04, 2005 |
| Decision Date | May 26, 2005 |
| Days to Decision | 111 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. |