Cleared Traditional

Sheridan Spiral-Flex Endotracheal Tubes

K192324 · Teleflexmedical, Inc. · Anesthesiology
Dec 2019
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K192324 is an FDA 510(k) clearance for the Sheridan Spiral-Flex Endotracheal Tubes, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on December 6, 2019, 101 days after receiving the submission on August 27, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K192324 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 2019
Decision Date December 06, 2019
Days to Decision 101 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTR — Tube, Tracheal (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5730

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