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XPS 3000 SYSTEM

FDA 510(k)

Class II (US FDA 510(k))

510(k) K002224

by Medtronic Xomed

Identifiers

510(k) Number
K002224 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, classified under ENT (Ear, Nose, Throat) specialty. It is a powered surgical system designed for precision cutting, drilling, and resection in ENT and related procedures.

The device is supplied as a reusable system requiring maintenance and testing by authorized personnel. It is regulated under FDA 510(k) clearance (K002224) with product code ERL and regulation number 874.4250, and is intended for use in clinical settings by trained professionals.

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 XPS Model 3000 System User's Gui, Medtronic XOMED XPS 3000 Microdebrider w/ Foot Switch, 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

Sources (1)

  • FDA 510(k) K002224 24 fields · synced Sep 22, 2026