Device Recall TX1 Tissue Removal System Console

  • Modèle / numéro de série
    Product Codes: LFL, GEI,  Serial #: 55400001, 55400002, 55400003. Part Order No: 554-0034-000 510(K) Mp.: K101561
  • Classification du dispositif
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution: MN only.
  • Description du dispositif
    TX1 Tissue Removal System Console. Model: TX1 || TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the user interface via LCD touchscreen and audible tones for confirmation of user selections. || Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    American Optisurgical Inc, 26902 Vista Ter, Lake Forest CA 92630-8123
  • Source
    USFDA