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FDA 510(k)

Disposable Endobronchial Blocker Tube

K-Number: K232580 · 2023-12-14

ApplicantShenzhen Insighters Medical Technology Co., Ltd.
Decision Date2023-12-14
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Disposable Endobronchial Blocker Tube is a medical device manufactured by Shenzhen Insighters Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-14 under approval number K232580. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Endobronchial Blocker Tube?

Disposable Endobronchial Blocker Tube is a medical device that received FDA 510(k) clearance on 2023-12-14. It is manufactured by Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232580.

When was Disposable Endobronchial Blocker Tube approved by the FDA?

Disposable Endobronchial Blocker Tube received FDA 510(k) clearance on 2023-12-14, under approval number K232580.

What company makes Disposable Endobronchial Blocker Tube?

Disposable Endobronchial Blocker Tube is manufactured by Shenzhen Insighters Medical Technology Co., Ltd..

What is the FDA product code for Disposable Endobronchial Blocker Tube?

The FDA product code for Disposable Endobronchial Blocker Tube is CBI.

Other Devices by Shenzhen Insighters Medical Technology Co., Ltd.

K232529Disposable Double Lumen Endobronchial Tube K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.

Related Devices (Code: CBI)

K1605425.0 Fr Arndt Endobronchial Blocker SetCook Incorporated K152251Endobronchial TubeHenan Tuoren Medical Device Co., Ltd. K181886VivaSight-DL SystemEtview , Ltd. K180253Sheridan Endobronchial TubesTeleflex Medical K200968ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39RInsung Medical Co., Ltd. K201026sOLVe TubeHytek Medical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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