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Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K161656

by Ambu A/S

Identifiers

510(k) Number
K161656 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 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, and Ambu aView Monitor are single-use sterile flexible videoscopes with working channel widths of 2.2 mm, 1.2 mm, and 2.8 mm respectively. These devices are designed for use with endoscopic accessories and can be used with ET tubes size 6 and up for the Regular model, and size 5 and up for the Slim model. The aScope 3 Regular is suitable for procedures requiring a minimum working channel width up to 2.0 mm, while the aScope 3 Slim accommodates accessories with a minimum working channel width up to 1.2 mm.

The devices are supplied as single-use sterile items and are intended for use in settings such as the operating room and emergency room for airway management. They are available in different sizes to accommodate various clinical needs. The product has received FDA 510(k) clearance with the product code EOQ and was reviewed by the Ear, Nose, Throat advisory committee. The devices are manufactured by Ambu A/S and are stored according to the manufacturer's instructions.

Frequently asked questions

What are the different models of Ambu aScope 3 available and their specifications?

The Ambu aScope 3 line includes three models: Regular 5.0/2.2 with a 2.2mm working channel, Slim 3.8/1.2 with a 1.2mm working channel, and Large 5.8/2.8 with a 2.8mm working channel. Each model is designed for different clinical needs and accessory requirements.

Are these devices single-use or reusable?

The Ambu aScope 3 videoscopes are supplied as single-use sterile items and are not intended for reuse. They are designed to be discarded after a single procedure to ensure patient safety and prevent cross-contamination.

What are the compatible ET tube sizes for each model?

The Ambu aScope 3 Regular model is compatible with ET tubes size 6 and up, while the Slim model accommodates ET tubes size 5 and up. The Large model's ET tube compatibility is not specified in the available information.

What is the regulatory status of these devices?

The Ambu aScope 3 videoscopes have received FDA 510(k) clearance with product code EOQ. They were reviewed by the Ear, Nose, and Throat advisory committee and received a decision code of SESE (Substantially Equivalent Special).

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: PDF Ambu® aScope™ 3 5.0/2.2 & aScope™ 3 Slim 3.8/1.2 Ambu® - KRUUSE, Ambu aScope 3 and Ambu aScope 3 Slim Ambu®, Ambu aScope 3 5.0/2.2 Instructions For Use Manual, Ambu aScope 3 Regular 5.0/2

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ambu A/S

Sources (1)

  • FDA 510(k) K161656 24 fields · synced Sep 22, 2026