Cleared Abbreviated

SMITH & NEPHEW INSTRUMENT TRAYS

K073551 · Smith & Nephew Inc., Endoscopy Div. · General Hospital

May 2008

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K073551 is an FDA 510(k) clearance for the SMITH & NEPHEW INSTRUMENT TRAYS, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Smith & Nephew Inc., Endoscopy Div. (Mansfield, US). The FDA issued a Cleared decision on May 21, 2008, 155 days after receiving the submission on December 18, 2007. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K073551 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 18, 2007
Decision Date	May 21, 2008
Days to Decision	155 days
Submission Type	Abbreviated
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.6850