K201400 is an FDA 510(k) clearance for the npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™. This device is classified as a Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical (Class II - Special Controls, product code QPX).
Submitted by Aatru Medical, LLC (Cleveland, US). The FDA issued a Cleared decision on August 23, 2021, 452 days after receiving the submission on May 28, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4683. 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. 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 | K201400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 2020 |
| Decision Date | August 23, 2021 |
| Days to Decision | 452 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QPX - Negative Pressure Wound Therapy, Non-powered Suction Pump, Chemical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4683 |
| 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. Indicated For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds, Partial-thickness Burns, Ulcers (such As Diabetic Or Pressure), Flaps And Grafts. |