Cleared Traditional

CUFF PILOT, SURE SEAL

K142103 · Teleflexmedical, Inc. · Anesthesiology
May 2015
Decision
280d
Days
Class 2
Risk

About This 510(k) Submission

K142103 is an FDA 510(k) clearance for the CUFF PILOT, SURE SEAL, a Cuff, Tracheal Tube, Inflatable (Class II — Special Controls, product code BSK), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on May 8, 2015, 280 days after receiving the submission on August 1, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5750.

Submission Details

510(k) Number K142103 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2014
Decision Date May 08, 2015
Days to Decision 280 days
Submission Type Traditional
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