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Intuitive Surgical Endoscopic Instrument Control System & Endoscopic Instruments, Model Da Vinci ISI 1000/1200

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022574

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K022574 FDA 510(k)
FDA Product Code
NAY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.1500 FDA 510(k)
Regulation Number
876.1500 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Intuitive Surgical Endoscopic Instrument Control System is a computer-controlled surgical system designed to assist in the accurate control of endoscopic instruments during urologic, general laparoscopic, and gynecologic laparoscopic surgical procedures. The system includes the Da Vinci ISI 1000/1200 model and various endoscopic instruments that extend the capabilities of surgeons by mimicking and magnifying hand movements with a greater range of motion.

The system is supplied as a multi-use device and is not MRI safe. It is authorized under FDA 510(k) clearance with product code NAY and is classified as a Class II device. The system is intended for use in hospital settings and requires appropriate storage conditions. The device has received clearance for use in gastroenterology and urology specialties.

Frequently asked questions

What is the Da Vinci ISI 1000/1200 system used for?

The Da Vinci ISI 1000/1200 system is a computer-controlled surgical system designed to assist in the accurate control of endoscopic instruments during urologic, general laparoscopic, and gynecologic laparoscopic surgical procedures.

Is the Da Vinci ISI 1000/1200 system single-use or multi-use?

The system is supplied as a multi-use device and is not MRI safe. It is intended for use in hospital settings and requires appropriate storage conditions.

What regulatory approvals does the Da Vinci ISI 1000/1200 system have?

The system is authorized under FDA 510(k) clearance with product code NAY and is classified as a Class II device. It has received clearance for use in gastroenterology and urology specialties.

What specialties can use the Da Vinci ISI 1000/1200 system?

The system is intended for use in gastroenterology and urology specialties, as well as general laparoscopic procedures, providing enhanced capabilities by mimicking and magnifying hand movements with a greater range of motion.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF Da Vinci X - Intuitive Surgical, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL… - FDA.report, Robotic Surgical Instruments | Da Vinci | Intuitive

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Intuitive Surgical, Inc.

Sources (1)

  • FDA 510(k) K022574 24 fields · synced Sep 26, 2026