Cleared Traditional

STRYKER ESSX MICRODEBRIDER SYSTEM

K073633 · Stryker Ireland Ltd., Instruments Division · Ear, Nose, Throat

Aug 2008

Decision

244d

Days

Class 2

Risk

About This 510(k) Submission

K073633 is an FDA 510(k) clearance for the STRYKER ESSX MICRODEBRIDER SYSTEM, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by Stryker Ireland Ltd., Instruments Division (Carrigtwohill, Co.Cork, IE). The FDA issued a Cleared decision on August 26, 2008, 244 days after receiving the submission on December 26, 2007. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.

Submission Details

510(k) Number	K073633 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2007
Decision Date	August 26, 2008
Days to Decision	244 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