Device Recall Encision AEM Suction Irrigation Electrode, Spatula

  • Modèle / numéro de série
    Catalog: REF ES3882,  Lots: QI, RA, RD, RE and RF.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
  • Description du dispositif
    Encision AEM Suction Irrigation Electrode, Spatula, || REF ES3882, || Encision Inc., || Boulder, CO 80301. || The Suction Irrigation Electrodes and Adapters combine AEM shielding technology with suction and irrigation of fluids during laparoscopic electrosurgery to cut and coagulate tissue. The electrodes connect to a compatible electrosurgical generator via an adapter on the Encision AEM Monitor.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Encision, Inc., 6797 Winchester Cir, Boulder CO 80301-3513
  • Société-mère du fabricant (2017)
  • Source
    USFDA