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K Number
K002224
Device Name
XPS 3000 SYSTEM
Manufacturer
MEDTRONIC XOMED
Date Cleared
2000-12-04

(133 days)

Product Code
ERL
Regulation Number
874.4250
Type
Traditional
Panel
Ear Nose & Throat
Reference & Predicate Devices
N/A
Predicate For
K041413,K041523,K073255
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.