K214112 is an FDA 510(k) clearance for the Invia Ease Negative Pressure Wound Therapy (NPWT) System. This device is classified as a Negative Pressure Wound Therapy Powered Suction Pump (Class II — Special Controls, product code OMP).
Submitted by Medela AG (Baar, CH). The FDA issued a Cleared decision on July 26, 2022, 208 days after receiving the submission on December 30, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4780. 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..
| 510(k) Number | K214112 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 30, 2021 |
| Decision Date | July 26, 2022 |
| Days to Decision | 208 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. |