K210107 is an FDA 510(k) clearance for the Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System, a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP), submitted by Genadyne Biotechnologies, Inc. (Hicksville, US). The FDA issued a Cleared decision on June 1, 2022, 502 days after receiving the submission on January 15, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4780.
| 510(k) Number | K210107 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 15, 2021 |
| Decision Date | June 01, 2022 |
| Days to Decision | 502 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. |