Disposable Endotracheal Tube, Sterile, AccuCuff

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K160694

by Tianjin Medis Medical Device Co., Ltd.

Identifiers

510(k) Number: K160694 FDA 510(k)
FDA Product Code: BTR FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 868.5730 FDA 510(k)
Regulation Number: 868.5730 FDA 510(k)
Advisory Committee: Anesthesiology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The Disposable Endotracheal Tube, Sterile, AccuCuff is a single-use, sterile airway management device designed for oral or nasal intubation. It features an inflatable cuff to ensure a secure seal within the trachea, reducing the risk of aspiration and improving ventilation during anesthesia or mechanical ventilation procedures.

This device is intended for use in clinical settings such as operating rooms, intensive care units, and emergency departments. Supplied sterile and disposable, it eliminates the need for reprocessing and reduces infection risks. The AccuCuff includes a pressure-monitoring system to maintain optimal intra-cuff pressure, ensuring effective sealing. Authorized under FDA 510(k) and MDR compliance, it adheres to regulatory standards for Class II medical devices.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disposable Endotracheal tube, sterile, AccuCuff (K160694) — FDA 510(k ..., Medis Medical, Medis Medical, Disposable Endotracheal tube, sterile, AccuCuff - BEUDAMED

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K160694	Class II	Active

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Manufacturer

Manufacturer: Tianjin Medis Medical Device Co., Ltd.

Sources (2)

FDA 510(k) K160694 24 fields · synced Oct 6, 2026
EUDAMED 1 fields · synced Jun 20, 2026