Cleared Traditional

K041985 - XPS CURVED BUR
(FDA 510(k) Clearance)

K041985 · Medtronic Xomed, Inc. · Ear, Nose, Throat device

Aug 2004

Decision

20d

Days

Class 1

Risk

K041985 is an FDA 510(k) clearance for the XPS CURVED BUR. This device is classified as a Bur, Ear, Nose And Throat (Class I - General Controls, product code EQJ).

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on August 12, 2004, 20 days after receiving the submission on July 23, 2004.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4140.

Submission Details

510(k) Number	K041985 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 23, 2004
Decision Date	August 12, 2004
Days to Decision	20 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF