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Bronchoscope System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K211169

by Shanghai Anqing Medical Instrument Co., Ltd

Identifiers

510(k) Number
K211169 FDA 510(k)
FDA Product Code
EOQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.4680 FDA 510(k)
Regulation Number
874.4680 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bronchoscope System is a flexible or rigid endoscope designed for visual examination of the airways, including the trachea and bronchi. It enables direct visualization of the respiratory tract, facilitating diagnostic procedures such as biopsy, secretion removal, and foreign body retrieval. This device is classified under the Ear, Nose, and Throat specialty and is intended for use in clinical settings requiring airway assessment or intervention.

This system is supplied as a reusable medical device, adhering to regulatory standards outlined in classification name Bronchoscope (flexible or rigid) under Regulation 874.4680. It is intended for use in controlled clinical environments, with specifications and safety validated through an FDA 510(k) submission (K211169). The device’s design and functionality are substantiated as substantially equivalent to predicate technologies, ensuring compliance with Ear, Nose, and Throat procedural requirements.

Frequently asked questions

What is the Bronchoscope System used for in clinical settings?

The Bronchoscope System is designed for direct visualization of the airways, including the trachea and bronchi. It supports diagnostic procedures like biopsy, secretion removal, and retrieval of foreign bodies, making it essential for airway assessment and intervention in controlled clinical environments.

Is the Bronchoscope System reusable or single-use?

This device is supplied as a reusable medical instrument, adhering to regulatory standards for Bronchoscopes (flexible or rigid) under Regulation 874.4680. Reusability is validated through rigorous cleaning, sterilization, and maintenance protocols to ensure safety and functionality across multiple procedures.

What regulatory pathway was followed for this bronchoscope?

The Bronchoscope System received FDA clearance through a 510(k) submission (K211169), demonstrating substantial equivalence to predicate technologies. This pathway confirms compliance with Ear, Nose, and Throat procedural requirements and ensures the device meets established safety and performance standards.

How is the device classified under regulatory guidelines?

The Bronchoscope System falls under the Ear, Nose, and Throat (ENT) specialty classification, specifically as a Bronchoscope (flexible or rigid). This classification aligns with its intended use for airway examination and intervention in clinical settings, guiding its regulatory oversight and submission process.

What distinguishes this bronchoscope from other similar devices?

This system is uniquely identified by its FDA 510(k) clearance (K211169) and its manufacturer, Shanghai Anqing Medical Instrument Co., Ltd. The device’s reusable design, validated through substantial equivalence, ensures it meets rigorous clinical standards for airway visualization and procedural support in ENT applications.

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: Bronchoscope System 510 (k) K211169 - FDA.report, Shanghai AnQing Medical Instrument Co., Ltd. 510(k) Products, PDF November 24, 2021 Shanghai AnQing Medical Instrument CO., Ltd. ℅ Olivia ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Shanghai Anqing Medical Instrument Co., Ltd
FDA Applicant
Shanghai AnQing Medical Instrument Co., Ltd.

Sources (1)

  • FDA 510(k) K211169 24 fields · synced Oct 1, 2026