Da Vinci Instruments
Delivering precision beyond the limits of the human hand
Our carefully curated, wide-ranging collection of da Vinci instruments empowers you to deliver the benefits of robotic-assisted surgery with incredible precision to your patients. Inspired by the human hand—but with a greater range of motion—our graspers, needle drivers, clip appliers, staplers, and energy instruments are designed to extend your capabilities. Whether you’re using the da Vinci 5, X, Xi, or SP system, our surgical tools mimic and magnify your movements, seamlessly adjusting hand-to-instrument ratios. Tremor reduction technology further enhances your fingertip control, so you can feel confident delivering minimally invasive care across a range of procedures.
“Patients first” has always been core to our mission. Patient safety, product efficacy, and delivering improvements in clinical outcomes guide the design, testing, and manufacture of our surgical systems, instruments, and accessories.
With these objectives in mind, we have designed and rigorously tested and validated our EndoWrist instruments with usage and reprocessing limits intended to provide consistent product performance from the first use to the last.
We are aware that third parties may seek to offer products or services to healthcare providers that would modify some of our instruments to extend their use. It is our understanding that such modifications constitute remanufacturing under FDA regulations and require 510(k) clearance from FDA.
We recognize the role that third-party medical device servicers have come to play in the medical device ecosystem, and we support healthy, lawful competition in the marketplace. We also have a responsibility to protect patient safety and provide customers with proven, safe, and effective tools and technologies.
Our customers should know that Intuitive will not void its service contract with, cease doing business with, or consider it a breach of contract by a customer in the United States who chooses to purchase remanufactured instruments that have been remanufactured by a third party pursuant to and in compliance with a 510(k) clearance or equivalent granted by the FDA.
Third parties also have the option to participate in Intuitive’s compatibility process, whereby they would submit clinical safety data to Intuitive and work directly with Intuitive to ensure patient safety and validate compatibility of remanufactured devices with da Vinci. However, when remanufacturing of EndoWrists is performed by third parties that choose to not participate in Intuitive’s third party compatibility process, we do not have appropriate access to their testing protocols, verifications and validations, remanufacturing processes, or quality controls, among other things. Accordingly, Intuitive will not bear responsibility for instruments that are remanufactured by a third party, or for harms or damages caused by the use of such instruments.
As of March 15, 2025, Intuitive is aware that FDA has granted the following 510(k) clearances to third parties for the remanufacture of EndoWrist instruments:
| Device Name | Product Number | Da Vinci System(s) | Third-Party 510(k) Applicant | 510(k) Number | Participate in Intuitive’s 3rd Party Compatibility Process |
|---|---|---|---|---|---|
| 8mm Monopolar Curved Scissors | S, Si | Iconocare Health | K210478 | No | |
| Remanufactured EndoWrist ProGrasp Forceps | 420093 | S, Si | Rebotix | K241872 | No |
| 8 mm Monopolar Curved Scissors (470179) | 470179 | X/Xi | Iconocare Health | K242610 | No |
For more information about 510(k) clearances granted by FDA, please refer to FDA’s publicly available searchable database.
Important safety information
For product intended use and/or indications for use, risks, cautions, and warnings and full prescribing information, refer to the associated user manual(s) or visit https://manuals.intuitivesurgical.com/market. For summary of the risks associated with surgery refer to www.intuitive.com/safety.
