Abc33l, Abc35l, Abc37l, Abc39l, Abc33r, Abc35r, Abc37r, Abc39r
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K200968 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 ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R is a tracheal/bronchial tube for differential ventilation with or without connector. This device is classified as a Class II medical device under product code CBI with special controls.
The device is manufactured by Insung Medical Co., Ltd. and received FDA 510(k) clearance with number K200968 on December 28, 2020, as substantially equivalent. It is regulated under number 868.5740 and is intended for use in anesthesiology settings.
Frequently asked questions
What is the purpose of the ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R tracheal/bronchial tube?
This device is designed for differential ventilation procedures in anesthesiology settings. It allows for separate ventilation of each lung when needed, with or without a connector, providing clinicians with flexibility in managing patient ventilation during surgical procedures.
What are the available models and sizes for this tracheal/bronchial tube?
The device is available in multiple models including ABC33L, ABC35L, ABC37L, ABC39L for left-sided use and ABC33R, ABC35R, ABC37R, ABC39R for right-sided use. The numbers likely indicate different sizes to accommodate various patient anatomies, though specific dimensions aren't provided in the available data.
What is the regulatory status of this device?
This tracheal/bronchial tube has received FDA 510(k) clearance with number K200968 on December 28, 2020, as substantially equivalent. It is classified as a Class II medical device under product code CBI with special controls and is regulated under number 868.5740.
How is this device supplied and what are its storage requirements?
The device data doesn't specify packaging details or storage requirements. As a tracheal/bronchial tube intended for medical procedures, it would typically be supplied in sterile packaging appropriate for clinical use. For specific storage conditions and shelf life, users should consult the manufacturer's instructions for use.
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: Abc33l, Abc35l, Abc37l, Abc39l, Abc33r, Abc35r, Abc37r, Abc39r, ABC33L, ABC35L, ABC37L, ABC39L, ABC33R,... (K200968) - FDA 510(k), ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200968 | Class II | Active |
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Manufacturer
- Manufacturer
- INSUNG MEDICAL Co., Ltd..
- FDA Applicant
- Insung Medical Co., Ltd.
Sources (1)
- FDA 510(k) K200968 24 fields · synced Oct 6, 2026