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FDA 510(k)

Disposable Double Lumen Endobronchial Tube

K-Number: K232529 · 2024-05-13

Decision Date2024-05-13
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Disposable Double Lumen Endobronchial Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232529. 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 Double Lumen Endobronchial Tube?

Disposable Double Lumen Endobronchial Tube is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232529.

When did Disposable Double Lumen Endobronchial Tube receive FDA 510(k) clearance?

Disposable Double Lumen Endobronchial Tube received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232529.

Who is the listed applicant for Disposable Double Lumen Endobronchial Tube?

The FDA 510(k) record lists Shenzhen Insighters Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Double Lumen Endobronchial Tube?

The FDA product code for Disposable Double Lumen Endobronchial Tube is CBI.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Shenzhen Insighters Medical Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: CBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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