Intuitive Surgical® da Vinci Xi® Endoscopic Instrument Control System (da Vinci Xi System) and Endoscopic Instruments - HSA Registration DE0500751
Access comprehensive regulatory information for Intuitive Surgical® da Vinci Xi® Endoscopic Instrument Control System (da Vinci Xi System) and Endoscopic Instruments in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0500751 and owned by Intuitive Surgical, Inc.. The device was registered on October 12, 2017.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System Model IS4000) 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 transoral 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 transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment.

