Cleared Traditional

Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube

K150603 · Teleflexmedical, Inc. · Anesthesiology
Nov 2015
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K150603 is an FDA 510(k) clearance for the Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube, a Tube, Tracheal (w/wo Connector) (Class II — Special Controls, product code BTR), submitted by Teleflexmedical, Inc. (Durham, US). The FDA issued a Cleared decision on November 27, 2015, 262 days after receiving the submission on March 10, 2015. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5730.

Submission Details

510(k) Number K150603 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2015
Decision Date November 27, 2015
Days to Decision 262 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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