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5mm/8mm Harmonic Ace(tm) Curved Shears, Disposable Harmonic Ace(tm) Insert, Dis…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K112584

by Intuitive Surgical, Inc.

Identifiers

510(k) Number
K112584 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 5MM/8MM Harmonic ACE Curved Shears is a disposable surgical instrument designed for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is intended to be used in conjunction with the da Vinci Surgical Systems and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

This device is supplied as a disposable instrument and is not for reuse. It is regulated under FDA 510(k) clearance with product code NAY and is classified as a Class II device. The device is indicated for use in general, plastic, pediatric, gynecologic, urologic, and thoracic surgeries, including exposure to orthopedic structures such as spine and joint space.

Frequently asked questions

What is the Harmonic ACE Curved Shears used for?

The Harmonic ACE Curved Shears is a disposable surgical instrument designed for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is intended for use in general, plastic, pediatric, gynecologic, urologic, and thoracic surgeries, including exposure to orthopedic structures such as spine and joint space.

Is the Harmonic ACE Curved Shears reusable?

No, this device is supplied as a disposable instrument and is not for reuse. It is designed for single-use procedures to ensure optimal performance and safety.

What systems is the Harmonic ACE Curved Shears compatible with?

The Harmonic ACE Curved Shears is designed to be used in conjunction with the da Vinci Surgical Systems and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

What is the regulatory classification of this device?

The device is regulated under FDA 510(k) clearance with product code NAY and is classified as a Class II device. It received FDA clearance on September 29, 2011.

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: 5mm/8mm Harmonic Ace (Tm) Curved Shears, Disposable Harmonic Ace (Tm ..., HARMONIC ACE+ Shears | Adaptive Tissue | J&J MedTech, K112584 FDA 510(k) - 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS

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) K112584 24 fields · synced Sep 24, 2026