Cleared Traditional

Tracheal Stent System

K202204 · Micro-Tech (Nanjing) Co., Ltd. · Anesthesiology
Sep 2021
Decision
392d
Days
Class 2
Risk

About This 510(k) Submission

K202204 is an FDA 510(k) clearance for the Tracheal Stent System, a Prosthesis, Tracheal, Expandable (Class II — Special Controls, product code JCT), submitted by Micro-Tech (Nanjing) Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on September 1, 2021, 392 days after receiving the submission on August 5, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K202204 FDA.gov
FDA Decision Cleared SESE
Date Received August 05, 2020
Decision Date September 01, 2021
Days to Decision 392 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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