Cleared Traditional

LMA FASTRACH ETT SINGLE USE

K051993 · The Laryngeal Mask Co., Ltd. · Anesthesiology
Dec 2005
Decision
141d
Days
Class 2
Risk

About This 510(k) Submission

K051993 is an FDA 510(k) clearance for the LMA FASTRACH ETT SINGLE USE, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by The Laryngeal Mask Co., Ltd. (San Diego, US). The FDA issued a Cleared decision on December 13, 2005, 141 days after receiving the submission on July 25, 2005. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K051993 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2005
Decision Date December 13, 2005
Days to Decision 141 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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