Cleared Traditional

Disposable Endobronchial Blocker Tube

K232580 · Shenzhen Insighters Medical Technology Co., Ltd. · Anesthesiology

Dec 2023

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K232580 is an FDA 510(k) clearance for the Disposable Endobronchial Blocker 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 December 14, 2023, 111 days after receiving the submission on August 25, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5740.

Submission Details

510(k) Number	K232580 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2023
Decision Date	December 14, 2023
Days to Decision	111 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