Cleared Traditional

Through the Scope Tracheal Stent System

K220424 · Micro-Tech (Nanjing) Co., Ltd. · Anesthesiology
Jul 2022
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K220424 is an FDA 510(k) clearance for the Through the Scope 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 July 8, 2022, 144 days after receiving the submission on February 14, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 878.3720.

Submission Details

510(k) Number K220424 FDA.gov
FDA Decision Cleared SESE
Date Received February 14, 2022
Decision Date July 08, 2022
Days to Decision 144 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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