K090638 is an FDA 510(k) clearance for the GENADYNE A4-XLR8 WOUND VACUUM SYSTEM. This device is classified as a Negative Pressure Wound Therapy Powered Suction Pump (Class II - Special Controls, product code OMP).
Submitted by Genadyne Biotechnologies, Inc. (Great Neck, US). The FDA issued a Cleared decision on April 29, 2009, 50 days after receiving the submission on March 10, 2009.
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 | K090638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2009 |
| Decision Date | April 29, 2009 |
| Days to Decision | 50 days |
| Submission Type | Special |
| 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. |