Cleared Traditional

InterActive Complete Surgical Tray

K142519 · Implant Direct Sybron Manufacturing, LLC · General Hospital

Apr 2015

Decision

219d

Days

Class 2

Risk

About This 510(k) Submission

K142519 is an FDA 510(k) clearance for the InterActive Complete Surgical Tray, a Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (Class II — Special Controls, product code KCT), submitted by Implant Direct Sybron Manufacturing, LLC (Calabasas, US). The FDA issued a Cleared decision on April 15, 2015, 219 days after receiving the submission on September 8, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6850.

Submission Details

510(k) Number	K142519 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 08, 2014
Decision Date	April 15, 2015
Days to Decision	219 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