Cleared Traditional

XPS NITRO SYSTEM

K002828 · Xomed, Inc. · Ear, Nose, Throat

Oct 2000

Decision

36d

Days

Class 2

Risk

About This 510(k) Submission

K002828 is an FDA 510(k) clearance for the XPS NITRO SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 17, 2000, 36 days after receiving the submission on September 11, 2000. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K002828 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 2000
Decision Date	October 17, 2000
Days to Decision	36 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