Cleared Traditional

Disposable Double Lumen Endobronchial Tube

K232529 · Shenzhen Insighters Medical Technology Co., Ltd. · Anesthesiology

May 2024

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K232529 is an FDA 510(k) clearance for the Disposable Double Lumen Endobronchial Tube, a Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector) (Class II — Special Controls, product code CBI), submitted by Shenzhen Insighters Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on May 13, 2024, 266 days after receiving the submission on August 21, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K232529 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2023
Decision Date	May 13, 2024
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF

Device Classification

Product Code	CBI — Tube, Tracheal/bronchial, Differential Ventilation (w/wo Connector)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 868.5740