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Monopolar Curved Scissors Tip Cover Accessory

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112263

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K112263 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 Monopolar Curved Scissors Tip Cover Accessory is an electrically isolating sleeve designed for the distal tip of Monopolar Curved Scissors used with da Vinci Surgical Systems. It is classified as a System, Surgical, Computer Controlled Instrument under FDA device classification.

This accessory is supplied as part of the da Vinci instrument system and is intended for use in gastroenterology and urology procedures. It received FDA 510(k) clearance (K112263) as substantially equivalent to a predicate device and is regulated under regulation number 876.1500.

Frequently asked questions

What is the Monopolar Curved Scissors Tip Cover Accessory used for?

The Monopolar Curved Scissors Tip Cover Accessory is an electrically isolating sleeve designed for the distal tip of Monopolar Curved Scissors used with da Vinci Surgical Systems. It is intended for use in gastroenterology and urology procedures to provide electrical isolation during surgical operations.

How is the Monopolar Curved Scissors Tip Cover Accessory supplied?

The accessory is supplied as part of the da Vinci instrument system. It is not sold separately but is included as a component of the overall surgical instrument system designed for use with the da Vinci Surgical System.

What is the regulatory status of the Monopolar Curved Scissors Tip Cover Accessory?

The Monopolar Curved Scissors Tip Cover Accessory received FDA 510(k) clearance (K112263) as substantially equivalent to a predicate device. It is classified as a System, Surgical, Computer Controlled Instrument under FDA device classification and is regulated under regulation number 876.1500.

What procedures is the Monopolar Curved Scissors Tip Cover Accessory intended for?

This accessory is specifically intended for use in gastroenterology and urology procedures when used with Monopolar Curved Scissors and the da Vinci Surgical System. The electrical isolation provided by the tip cover is particularly important in these specialized surgical fields.

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 Intuitive Da Vinci X/Xi System Instrument and Accessory Catalog, PDF Da Vinci Multiport Instrument and Accessory Catalog, MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY (K112263) — FDA 510 (k ..., PDF OCT - 7 20W)A ll/23

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) K112263 24 fields · synced Oct 1, 2026