Needle Driver

  • Model / Serial
    Model numbers: 428056-12, 428056-13; all lots
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brazil, Canada, Chile, China, Cyprus, Denmark, France, Germany, Greece, Israel, Italy, Monaco, Netherlands, Panama, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom.
  • Product Description
    Needle Driver; used with the da Vinci Si Surgical System (IS3000); || Model numbers: 428056-12, 428056-13. || The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Intuitive Surgical, Inc., 1266 Kifer Rd Bldg 100, Sunnyvale CA 94086-5304
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

26 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: Models: INS-420006, INS-420194, INS-400006, INS-400194, Affected: Manufactured between July 2007 and October 2011
  • Manufacturer
  • Model / Serial
  • Product Description
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
  • Model / Serial
  • Product Description
    Surgical equipment/ Anaesthesia - surgical equipment
  • Manufacturer
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