Disposable Double Lumen Endobronchial Tube— 510(k) K232529

Name: FDA 510(k) clearance K232529
Creator: U.S. Food and Drug Administration
Published: 2024-05-13

Substantially Equivalent

Shenzhen Insighters Medical Technology Co., Ltd.

FDA 510(k) clearance K232529 for Disposable Double Lumen Endobronchial Tube, Substantially Equivalent on 2024-05-13. Applicant: Shenzhen Insighters Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Insighters Medical Technology Co., Ltd.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 2023-08-21
Decision date: 2024-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K232580 — Disposable Endobronchial Blocker Tube2023-12-14
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K201026 — sOLVe Tube2021-08-10

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Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.