Device Recall Urethral Warmer System

  • Modèle / numéro de série
    GW469, GW470, GW468, GW472
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA, including CA, GA, TX and the country of Canada.
  • Description du dispositif
    Urethral Warmer System Model number FPRCH3001 || The Urethral Warming System is designed to circulate a warm solution through a warming catheter to maintain urethral tissue near body temperatures while the surrounding prostate tissue is being frozen. It is intended to warm urethral tissue when performing cryogenic destruction of prostatic tissue with a Galil Medical Cryoablation System.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Galil Medical, 4364 Round Lake Road, Arden Hills MN 55112
  • Société-mère du fabricant (2017)
  • Source
    USFDA