Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Disposable Double Lumen Endobronchial Tube

K-Number: K232529 · 2024-05-13

ApplicantShenzhen Insighters Medical Technology Co., Ltd.
Decision Date2024-05-13
Product CodeCBI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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

When was Disposable Double Lumen Endobronchial Tube approved by the FDA?

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

What company makes Disposable Double Lumen Endobronchial Tube?

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

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

NCT07614529 Hyperangulated vs Standard Videolaryngoscopy vs Direct Laryngoscopy for Double-Lumen Endobronchial Tube Intubation NOT_YET_RECRUITING NCT06749496 Evaluation of Delefilcon A and Senofilcon A Daily Disposable Toric Soft Contact Lenses Over One Week of Wear COMPLETED NCT06967129 Evaluation of Daily Disposable Toric Soft Lenses Manufactured With an Alternative Hydration Process COMPLETED NCT06375967 EUS-Gallbladder vs CDS as First Line in MBDO- Palliative (CARPEGIEM Trial) SUSPENDED NCT07097584 Effect of Small Double-lumen Tube on the Intubation Time of Thoracoscopic Pulmonectomy in Asian Women COMPLETED

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

K232580Disposable Endobronchial Blocker 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.

↑