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XPS 3000 SYSTEM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041523

by Medtronic Xomed, Inc.

Identifiers

510(k) Number
K041523 FDA 510(k)
FDA Product Code
ERL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4250 FDA 510(k)
Regulation Number
874.4250 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The XPS 3000 SYSTEM is a surgical drill, electric or pneumatic, including handpiece, intended for use in ear, nose, and throat procedures. It is classified as a Class II medical device under regulation number 874.4250.

The device received traditional 510(k) clearance (K041523) and is substantially equivalent to a predicate device. It is manufactured by Medtronic Xomed, Inc. and is intended for use in ENT surgical settings as indicated by the advisory committee classification.

Frequently asked questions

What is the XPS 3000 SYSTEM used for?

The XPS 3000 SYSTEM is a surgical drill intended for use in ear, nose, and throat (ENT) procedures. It includes a handpiece and can be powered electrically or pneumatically, designed specifically for surgical applications in ENT settings as indicated by its advisory committee classification.

How is the XPS 3000 SYSTEM supplied and powered?

The XPS 3000 SYSTEM is supplied as a surgical drill system that includes a handpiece and is designed to operate using either electric or pneumatic power sources, allowing flexibility in surgical environments based on available equipment and surgeon preference.

Is the XPS 3000 SYSTEM reusable or single-use?

The device data does not specify whether the XPS 3000 SYSTEM or its components are single-use or reusable. As a surgical drill system with a handpiece, it may include reusable elements, but reprocessing instructions would need to be obtained from the manufacturer’s labeling, which is not provided in the source data.

What regulatory pathway was used for the XPS 3000 SYSTEM?

The XPS 3000 SYSTEM received traditional 510(k) clearance under number K041523, demonstrating substantial equivalence to a predicate device. This regulatory pathway is indicated by the clearance_type and decision_description fields in the device data.

What classification does the XPS 3000 SYSTEM have?

The XPS 3000 SYSTEM is classified as a Class II medical device under regulation number 874.4250, with a product code of ERL. This classification is based on its intended use as a surgical drill for ENT procedures and is confirmed by the device_class and regulation_number 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: Medtronic XOMED XPS 3000 Microdebrider w/ Foot Switch, PDF XPS Model 3000 System User's Gui, Medtronic Xomed XPS 3000 User manual - ManualMachine.com, PDF XPS Model 3000 System, PDF 2003-506 xps 3000 broch 1.0.qxd - Global Medical Endoscopy

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA 510(k) K041523 24 fields · synced Sep 22, 2026