Cleared Traditional

Venner PneuX? ETT (Endotracheal Tube) 6 mm, Venner PneuX? ETT (Endotracheal Tube) 7 mm, Venner PneuX? ETT (Endotracheal Tube) 8 mm, Venner PneuX? ETT (Endotracheal Tube) 9 mm

K192120 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology
Feb 2020
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K192120 is an FDA 510(k) clearance for the Venner PneuX? ETT (Endotracheal Tube) 6 mm, Venner PneuX? ETT (Endotracheal Tube) 7 mm, Venner PneuX? ETT (Endotracheal Tube) 8 mm, Venner PneuX? ETT (Endotracheal Tube) 9 mm, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Venner Medical (Singapore) Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on February 14, 2020, 192 days after receiving the submission on August 6, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K192120 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2019
Decision Date February 14, 2020
Days to Decision 192 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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