Cleared Traditional

CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM

K120117 · Codman & Shurtleff, Inc. · General Hospital

Apr 2012

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K120117 is an FDA 510(k) clearance for the CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on April 16, 2012, 90 days after receiving the submission on January 17, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K120117 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2012
Decision Date	April 16, 2012
Days to Decision	90 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