K212971 is an FDA 510(k) clearance for the NPseal. This device is classified as a Negative Pressure Wound Therapy Non-powered Suction Apparatus (Class II - Special Controls, product code OKO).
Submitted by Guard Medical, Inc. (Miami, US). The FDA issued a Cleared decision on February 10, 2022, 146 days after receiving the submission on September 17, 2021.
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 | K212971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2021 |
| Decision Date | February 10, 2022 |
| Days to Decision | 146 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. |