(96 days)
The Prodigy™ 800V NPWT System is indicated for use in patients that would benefit from a suction device particularly as the device may promote wound healing or for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious material from a patients airway or respiratory support system either during surgery or at the patients bedside.
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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Prodigy™ NPWT System, Model: Prodigy™ 800V). It confirms the device's substantial equivalence to a legally marketed predicate device.
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§ 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.