K193185 is an FDA 510(k) clearance for the Anscare SIMO Negative Pressure Wound Therapy (NPWT) System. This device is classified as a Negative Pressure Wound Therapy Non-powered Suction Apparatus (Class II - Special Controls, product code OKO).
Submitted by Benq Materials Corporation (Taoyuan, TW). The FDA issued a Cleared decision on May 4, 2020, 168 days after receiving the submission on November 18, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4683. A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended 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..
| 510(k) Number | K193185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2019 |
| Decision Date | May 04, 2020 |
| Days to Decision | 168 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OKO - Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4683 |
| Definition | A Non-powered Suction Apparatus Indicated For Negative Pressure Wound Therapy (npwt) That Is Intended 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. |