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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.

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CLASS C
DE0500751
Intuitive Surgical® da Vinci Xi® Endoscopic Instrument Control System (da Vinci Xi System) and Endoscopic Instruments
HSA Registration Number: DE0500751
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Product Description

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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General & Plastic Surgery
Registration Information
Registration Number
DE0500751
Registration Date
October 12, 2017
Change Notification Approval Date
February 26, 2025
Retention Due Date
October 11, 2025
Product Owner
Short Name
Intuitive Surgical, Inc.
Address
1266 Kifer Road, Sunnyvale, CA 94086, UNITED STATES
Registrant
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Importer
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349 5 JALAN KILANG BARAT, PETRO CENTRE, #09-00, SINGAPORE 159349
Model Information
Model Name(s)
ASSY,PSCART,IS4000,4-ARM(PS4000) ASSY,SSC,IS4000(SS4000) ASSY,SSC,IS4000,RECERTIFIED(SS4000) ASSY,VSS,IS4000,RECERTIFIED(VS4000) ASSY,PSC,IS4000,RECERTIFIED(PS4000) ASSY,VSS VISION SYSTEM,IS4000(VS4000) Accesssory Base Starter Kit EndoWrist® Stapler System Starter Kit EndoWrist® Stapler System Starter Kit without Cannulae Single-Site 5x300mm FLEXIBLE BLUNT OBTURATOR Single-Site 5X250MM FLEXIBLE BLUNT OBTURATOR SINGLE-SITE 10MM ACCESSORY CANNULA Single-Site 10MM BLUNT OBTURATOR 8 mm Instrument Cannula 8 mm Cannula, Long 8 mm Endoscope, 0˚ 8 mm Endoscope, 30˚ 8 mm endoscope plus, 0˚ 8 mm endoscope plus, 30˚ Cardiac Probe Grasper Atrial Retractor Short Right Stapler 45 8mm Flared/Grounded Cannula 8 mm Bladeless Obturator, Long 8 mm Bladeless Obturator 8 mm Bladeless Obturator, Long 12 mm & Stapler Cannula 12 - 8 mm Reducer 12 mm & Stapler Cannula, Long 8 mm Hasson Cone 12 mm & Stapler Hasson Cone 12 mm & Stapler Bladeless Obturator 12 mm & Stapler Bladeless Obturator, Long Stapler 30 EndoWrist® Stapler Cannula Kit Stapler 30 Curved-Tip Single-Site 8 mm Obturator Maryland Dissector Medium-Large Clip Applier Cadiere Forceps Curved Scissors Fundus Grasper Crocodile Grasper Single-Site® 5 mm Accessory Cannula Single-Site® 5 x 300 mm Curved Cannula (Endoscope Right) Single-Site® 5 x 300 mm Curved Cannula (Endoscope Left) Single-Site® Port for 8 mm Endoscope Single-Site® 5 x 250 mm Curved Cannula (Endoscope Right) Single-Site® 5 x 250 mm Curved Cannula (Endoscope Left) Bipolar Maryland Curved Needle Driver Permanent Cautery Hook Fenestrated Bipolar Forceps Wristed Needle Driver 5 -10 mm Single-Site® Cannula Seal Single-Site® 8 mm Endoscope Cannula Vessel Sealer Extend SureForm 45 12 mm Single Use Stapler SureForm 60 12 mm Single Use Stapler SureForm 45 Curved-Tip 12 mm Single Use Stapler SureForm 45 reload 45 mm Blue 6 - Row 3.5 mm SureForm 45 reload 45 mm Green 6 - Row 4.3 mm SureForm 45 reload 45mm Grey 6 - Row 2.0 mm SureForm 45 reload 45 mm Black 6 - Row 4.6 mm SureForm 45 reload 45 mm White 6 - Row 2.5 mm SureForm 60 reload 60 mm Blue 6 - Row 3.5 mm SureForm 60 reload 60 mm Green 6 - Row 4.3 mm SureForm 60 reload 60 mm Black 6 - Row 4.6 mm SureForm 60 reload 60 mm White 6 - Row 2.5 mm EndoWrist Stapler 45 Reload, 45 mm Green 4.3mm EndoWrist® Stapler 30 Reload, 30 mm Blue 3.5 mm EndoWrist® Stapler 30 Reload, 30 mm Green 4.3 mm EndoWrist® Stapler 30 Reload, 30 mm Gray 2.0 mm EndoWrist® Stapler 30 Reload, 30 mm White 2.5 mm EndoWrist Stapler 45 Reload, 45 mm Blue 3.5 mm EndoWrist Stapler 45 Reload, 45 mm White 2.5 mm
Model Identifier(s)
380652 380677 380797 380798 380799 381121 381200 381251 381252 428064 428074 428076 428084 470002 470004 470026 470027 470056 470057 470215 470246 470298 470319 470358 470359 470360 470375 470381 470389 470398 470399 470403 470404 470430 470443 470530 478008 478050 478053 478055 478057 478058 478059 478060 478061 478062 478065 478071 478072 478080 478088 478090 478093 478115 478161 478263 480422 480445 480460 480545 48345B 48345G 48345M 48345T 48345W 48360B 48360G 48360T 48360W 48445G 48630B 48630G 48630M 48630W 48645B 48645W