FDA 510(k), K043288, MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS

FDA 510(k), K043288, MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS

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510(K) Number: K043288
Device Name: MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS
Manufacturer: USHA KREADEN
Device Classification Name: System, Surgical, Computer Controlled Instrument
Regulation Number: NAY
Classification Product Code: KXA
Date Received: 11/29/2004
Decision Date: 03/03/2005
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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