Cleared Traditional

HANAROSTENT Trachea/Bronchium (CCC)

K201342 · M.I. Tech Co., Ltd. · Anesthesiology
Dec 2020
Decision
225d
Days
Class 2
Risk

About This 510(k) Submission

K201342 is an FDA 510(k) clearance for the HANAROSTENT Trachea/Bronchium (CCC), a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by M.I. Tech Co., Ltd. (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on December 31, 2020, 225 days after receiving the submission on May 20, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K201342 FDA.gov
FDA Decision Cleared SESE
Date Received May 20, 2020
Decision Date December 31, 2020
Days to Decision 225 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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