Intuitive Surgical Receives CE Mark for Latest da Vinci® Robotic-Assisted Surgical System

About the da Vinci Surgical System

There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body.

Intended Use

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.  The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures).  It is intended to be used by trained physicians in an operating room environment.

The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc.  Refer to the Instructions For Use before use.

Forward Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci X System in the US. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2016, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements using words such as "estimates," "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," "targeted" and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law.

© 2017 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders.

PN1035581rA EU 4/2017

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