Cleared Traditional

GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY

K120474 · Gyrus Acmi, Inc. · General Hospital

Jul 2012

Decision

145d

Days

Class 2

Risk

About This 510(k) Submission

K120474 is an FDA 510(k) clearance for the GYRUS ACMI TELESCOPE STORAGE-STERILIZATION TRAY, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Gyrus Acmi, Inc. (Southborough, US). The FDA issued a Cleared decision on July 10, 2012, 145 days after receiving the submission on February 16, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K120474 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 16, 2012
Decision Date	July 10, 2012
Days to Decision	145 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