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, Irr
| Device Type ID | 5810 |
| Device Name | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Physical State | Mechanical Pump And Wound Dressing Kit |
| Technical Method | The Wound Bed Is Dressed, Fitted With Mode Of Communication Between The Wound Bed And Suction Apparatus, And Sealed (according To Labeling Instructions). The Suction Apparatus Is Engaged To Create A Vacuum (negative Pressure) Within The Wound Bed Dri |
| Target Area | For Management Of Chronic, Acute, Traumatic, Subacute And Dehisced Wounds; Partial-thickness Burns; Ulcers (such As Diabetic Or Pressure) Flaps And Grafts. |
| Regulation Description | Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4683 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OKO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 5810 |
| Device | Negative Pressure Wound Therapy Non-powered Suction Apparatus |
| Product Code | OKO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Non-Powered Suction Apparatus Device Intended For Negative Pressure Wound Therapy. |
| CFR Regulation Number | 878.4683 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KCI USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
Compatibility Problem | 1 |
Patient-Device Incompatibility | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 5 |