K151436 is an FDA 510(k) clearance for the PICO Single Use Negative Pressure Wound Therapy System, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Smith & Nephew Medical, Ltd. (Hull, GB). The FDA issued a Cleared decision on January 28, 2016, 245 days after receiving the submission on May 28, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K151436 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 28, 2015 |
| Decision Date | January 28, 2016 |
| Days to Decision | 245 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. |