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Malleable Suction Instruments

FDA 510(k)

Class II (US FDA 510(k))

510(k) K133665

by Medtronic Navigation, Inc.

Identifiers

510(k) Number
K133665 FDA 510(k)
FDA Product Code
PGW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4560 FDA 510(k)
Regulation Number
882.4560 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Malleable Suction Instruments are sterile, single-use instruments intended for use with ENT software. They feature built-in AxiEM navigation technology within the instrument tip and are designed to be bent as necessary during operation without requiring re-verification.

The instruments are indicated for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust. They are intended for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software.

Frequently asked questions

What are Malleable Suction Instruments used for?

Malleable Suction Instruments are intended for use in ENT procedures where surgical navigation or image-guided surgery may be necessary to locate and remove fluids, semi-fluid substances, tissue, and bone dust.

Are these instruments reusable or single-use?

Malleable Suction Instruments are sterile, single-use instruments that are not intended to be reused. They should be discarded after a single procedure to maintain sterility and ensure optimal performance.

How are these instruments supplied?

The instruments are supplied sterile and ready for use. They feature built-in AxiEM navigation technology within the instrument tip and can be bent as necessary during operation without requiring re-verification.

What systems are compatible with these instruments?

Malleable Suction Instruments are designed for use with Medtronic computer-assisted surgery systems using electromagnetic navigation and Medtronic ENT software. They are not compatible with other navigation systems.

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: Malleable suction instruments | Medtronic, MALLEABLE SUCTION INSTRUMENTS (K133665) — FDA 510(k) | Innolitics, Malleable Suction Instruments M - thiemed.cl, PDF MAR 1 3 2014 - Food and Drug Administration

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Navigation, Inc.

Sources (1)

  • FDA 510(k) K133665 24 fields · synced Sep 25, 2026