Cleared Traditional

XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC)

K081277 · Medtronic Xomed, Inc. · Ear, Nose, Throat
Sep 2008
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K081277 is an FDA 510(k) clearance for the XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC), a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 5, 2008, 123 days after receiving the submission on May 5, 2008. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number K081277 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 2008
Decision Date September 05, 2008
Days to Decision 123 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

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