Cleared Traditional

SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY

K102544 · Smith & Nephew Inc., Endoscopy Div. · General Hospital

Jan 2011

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K102544 is an FDA 510(k) clearance for the SMITH & NEPHEW HIP ARTHROSCOPY REPAIR INSTRUMENT TRAY, 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 January 5, 2011, 124 days after receiving the submission on September 3, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K102544 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2010
Decision Date	January 05, 2011
Days to Decision	124 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