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Da Vinci Single-Site Permanent Cautery Hook

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130726

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K130726 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
SESU FDA 510(k)

The Da Vinci Single-Site Permanent Cautery Hook is a computer controlled instrument used in surgical procedures. It is a type of robotic instrument, specifically designed for single-site surgery. The device is used for permanent cautery, which involves the use of heat to cut and coagulate tissue.

The Da Vinci Single-Site Permanent Cautery Hook is supplied in various sizes, including 5 mm and 8 mm. It is compatible with the da Vinci Si and Xi robots. The device is available in new and repackaged conditions, with 10 uses per unit. It is classified as a class 2 device, with a regulation number of 876.1500, and has been authorized by the FDA with a 510(k) clearance, specifically K130726.

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: Single Site, Permanent Cautery Hook - R2 Surgical, Permanent Cautery Hook - R2 Surgical, PDF Intuitive Da Vinci X/Xi System Instrument and Accessory Catalog, PDF Intuitive Da Vinci X/Xi System Instrument and ... - Intuitive Surgical, DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK (K130726) — FDA 510(k ...

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) K130726 24 fields · synced Sep 21, 2026