Cleared Traditional

RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET

K130405 · Teleflex Medical · Anesthesiology
Nov 2013
Decision
260d
Days
Class 2
Risk

About This 510(k) Submission

K130405 is an FDA 510(k) clearance for the RUSCH EASYCRIC EMERGENCY CRICOTHYROTOMY SET, a Needle, Emergency Airway (Class II — Special Controls, product code BWC), submitted by Teleflex Medical (Durham, US). The FDA issued a Cleared decision on November 6, 2013, 260 days after receiving the submission on February 19, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5090.

Submission Details

510(k) Number K130405 FDA.gov
FDA Decision Cleared SESE
Date Received February 19, 2013
Decision Date November 06, 2013
Days to Decision 260 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BWC — Needle, Emergency Airway
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5090

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