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Silbroncho Double Lumen Tube

FDA 510(k)

Class II (US FDA 510(k))

510(k) K051522

by Fuji Systems Corp.

Identifiers

510(k) Number
K051522 FDA 510(k)
FDA Product Code
CBI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5740 FDA 510(k)
Regulation Number
868.5740 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Silbroncho Double Lumen Tube is a tracheal/bronchial differential ventilation tube classified as a Class II medical device. It consists of two lumens with separate cuffs for the bronchus and trachea, enabling selective one‑lung ventilation during anesthetic procedures.

The tube is constructed of 100 % silicone with a soft, flexible tip and a wire‑reinforced inner wall to prevent kinking and allow x‑ray verification. It is latex‑free, includes a stylet for reinforcement during intubation, and is supplied sterile for use in anesthesiology. The device received FDA 510(k) clearance (K051522) under product code CBI.

Frequently asked questions

What clinical situation is the Silbroncho Double Lumen Tube designed for?

It is intended for anesthetic procedures that require differential ventilation, allowing the clinician to isolate and ventilate one lung while the other remains collapsed, which is essential for thoracic surgery or lung isolation techniques.

How is the tube supplied and what materials are used?

The device is supplied sterile, includes a stylet for reinforcement during intubation, and is made of 100 % silicone with a soft tip. A wire‑reinforced inner wall prevents kinking and enables x‑ray verification, while the latex‑free construction reduces allergy risk.

Is the Silbroncho Double Lumen Tube reusable or single‑use?

The product is provided sterile for single‑use in anesthesiology. Single‑use design ensures consistent performance and eliminates the need for re‑processing, which could compromise the integrity of the silicone and cuff seals.

What features help prevent tube kinking and allow placement verification?

A wire‑reinforced inner wall gives the tube resistance to kinking during insertion, and the silicone material is radiopaque enough for x‑ray verification, helping clinicians confirm correct positioning of both lumens.

Under which regulatory pathway was the device cleared?

The Silbroncho Double Lumen Tube received FDA 510(k) clearance (K051522) under the traditional review pathway, indicating it was found substantially equivalent to a legally marketed predicate device.

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: SILBRONCHO™ | Fuji Systems Corporation, PDF H-512(13)_EAR-13_PHT Free - fujisys.co.jp, SILBRONCHO DOUBLE LUMEN TUBE (K051522) — FDA 510(k) | Innolitics, FUJI SYSTEMS SOLUTIONS FOR ONE LUNG VENTILATION

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Fuji Systems Corp.

Sources (1)

  • FDA 510(k) K051522 24 fields · synced Sep 26, 2026