Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Device Facts
| Record ID | K210107 |
|---|---|
| Device Name | Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System |
| Applicant | Genadyne Biotechnologies, Inc. |
| Product Code | OMP · General, Plastic Surgery |
| Decision Date | Jun 1, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4780 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.
