FDA 510(k)

Endobronchial Tube

K-Number: K152251 · 2016-06-10

ApplicantHenan Tuoren Medical Device Co., Ltd.

Decision Date2016-06-10

Product CodeCBI

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

Endobronchial Tube is the device name listed in this FDA 510(k) record. The listed applicant is Henan Tuoren Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K152251. 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 Endobronchial Tube?

Endobronchial Tube is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is Henan Tuoren Medical Device Co., Ltd.. The 510(k) number is K152251.

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

Endobronchial Tube received FDA 510(k) clearance on 2016-06-10, under 510(k) number K152251.

Who is the listed applicant for Endobronchial Tube?

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

What is the FDA product code for Endobronchial Tube?

The FDA product code for 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.

NCT07614529Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube IntubationNOT_YET_RECRUITING

Related Devices (Code: CBI)

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.