Devices

Device Recall VisualICE Cryoablation System

  • Modèle / numéro de série
    VL0004 VL0014 VL0015 VL0016
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US nationwide including the state of MN and the countries of United Kingdom and Netherlands
  • Description du dispositif
    Visual-ICE¿ Cryoablation System, Model FPRCH 6000 || Product Usage: The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures; various Galil Medical accessory products are required to perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts) by the application of extremely cold temperatures.
  • Manufacturer
    Galil Medical, Inc.
  • 1 Event

Fabricant

Galil Medical, Inc.
  • Adresse du fabricant
    Galil Medical, Inc., 4364 Round Lake Rd W, Arden Hills MN 55112
  • Société-mère du fabricant (2017)
    Btg Plc
  • Source
    USFDA