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Da Vinci S Surgical SYSTEM-V1.1, Model IS2000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063220

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K063220 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 Da Vinci S Surgical System-V1.1, Model IS2000 is a System, Surgical, Computer Controlled Instrument. It is classified under product code NAY and falls within the medical specialties of Gastroenterology and Urology.

This device received FDA 510(k) clearance under K063220 on December 1, 2006, and is designated as Class II with special controls. It was submitted by Intuitive Surgical, Inc. and is identified by the regulation number 876.1500.

Frequently asked questions

What is the Da Vinci S Surgical System-V1.1, Model IS2000 used for?

The Da Vinci S Surgical System-V1.1, Model IS2000 is a computer-controlled surgical instrument system intended for use in gastroenterology and urology procedures, as indicated by its product code NAY and medical specialty classification in the FDA 510(k) submission.

How was the Da Vinci S Surgical System-V1.1, Model IS2000 cleared for market?

The device received FDA 510(k) clearance under submission K063220 on December 1, 2006, based on a determination of substantial equivalence to a predicate device, and is classified as Class II with special controls under regulation number 876.1500.

Who manufactures the Da Vinci S Surgical System-V1.1, Model IS2000 and where is it registered?

The Da Vinci S Surgical System-V1.1, Model IS2000 is manufactured by Intuitive Surgical, Inc., headquartered in Sunnyvale, California, and is registered with the FDA under multiple FEI and registration numbers associated with the applicant and device listing.

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: DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 (K063220) — FDA 510 (k ..., PDF K063220 Da Vinci S Surgical System-v1.1, Model Is2000, K063220 FDA 510(k) - DA VINCI S SURGICAL SYSTEM-V1.1, Da Vinci S Surgical System-v1.1, Model Is2000

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) K063220 24 fields · synced Sep 22, 2026