Cleared Traditional

XPS 3000 SYSTEM

K002224 · Medtronic Xomed · Ear, Nose, Throat

Dec 2000

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K002224 is an FDA 510(k) clearance for the XPS 3000 SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on December 4, 2000, 133 days after receiving the submission on July 24, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K002224 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 24, 2000
Decision Date	December 04, 2000
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	ERL — Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4250