Cleared Traditional

SMITH & NEPHEW INSTRUMENT TRAYS

K092551 · Smith & Nephew Inc., Endoscopy Div. · General Hospital

Sep 2010

Decision

390d

Days

Class 2

Risk

About This 510(k) Submission

K092551 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. (Andover, US). The FDA issued a Cleared decision on September 14, 2010, 390 days after receiving the submission on August 20, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K092551 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 20, 2009
Decision Date	September 14, 2010
Days to Decision	390 days
Submission Type	Traditional
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