K Number
K210107
Device Name
Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System
Date Cleared
2022-06-01

(502 days)

Product Code
Regulation Number
878.4780
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
More Information

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

§ 878.4780 Powered suction pump.

(a)
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.(b)
Classification. Class II.

N/A