Cleared Special

PILOT TUBE REPAIR KIT

K113644 · Instrumentation Industries, Inc. · Anesthesiology
Jan 2012
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K113644 is an FDA 510(k) clearance for the PILOT TUBE REPAIR KIT, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on January 26, 2012, 45 days after receiving the submission on December 12, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K113644 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2011
Decision Date January 26, 2012
Days to Decision 45 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSK — Cuff, Tracheal Tube, Inflatable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5750