Cleared Traditional

BONASTENT TRACHEAL / BRONCHIAL

K140472 · Endochoice, Inc. · Anesthesiology
Oct 2014
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K140472 is an FDA 510(k) clearance for the BONASTENT TRACHEAL / BRONCHIAL, a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Endochoice, Inc. (Toronto, CA). The FDA issued a Cleared decision on October 17, 2014, 234 days after receiving the submission on February 25, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K140472 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2014
Decision Date October 17, 2014
Days to Decision 234 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code JCT — Prosthesis, Tracheal, Expandable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3720

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