Device Recall Intuiitve Surgical da Vinci EndoWrist

  • Model / Serial
    FDA Device Listing Number R100529, Model Number 400178-01. 510(k) number K021036.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to 84 medical facilities, located throughout the US and Switzerland, Belgium, Germany, Australia, Turkey and France.
  • Product Description
    Intuiitve Surgical da Vinci 8 mm EndoWrist Curved Scissors, in box. All lots. P/N 400178-01
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Intuitive Surgical, Inc., 950 Kifer Rd, Sunnyvale CA 94086-5206
  • Source
    USFDA