Cleared Traditional

Venner PneuX? TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 9.0 mm

K192511 · Venner Medical (Singapore) Pte, Ltd. · Anesthesiology
Jul 2020
Decision
314d
Days
Class 2
Risk

About This 510(k) Submission

K192511 is an FDA 510(k) clearance for the Venner PneuX? TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX? TT (Tracheostomy Tube) Size 9.0 mm, a Tube, Tracheostomy (w/wo Connector) (Class II — Special Controls, product code BTO), submitted by Venner Medical (Singapore) Pte, Ltd. (Singapore, SG). The FDA issued a Cleared decision on July 22, 2020, 314 days after receiving the submission on September 12, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5800.

Submission Details

510(k) Number K192511 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2019
Decision Date July 22, 2020
Days to Decision 314 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTO — Tube, Tracheostomy (w/wo Connector)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5800

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