Ambu aScope 4 RhinoLaryngo Slim
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K191080 FDA 510(k)
- FDA Product Code
- EOB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.4760 FDA 510(k)
- Regulation Number
- 874.4760 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ambu aScope 4 RhinoLaryngo Slim is a flexible or rigid nasopharyngoscope, designed for visual examination of the nasal passages and larynx. Its slim profile, with an outer diameter of 3.0 mm, facilitates minimally invasive procedures, reducing patient discomfort during rhinolaryngoscopy.
This single-use device is intended for use in outpatient clinics, emergency settings, or portable environments. Supplied sterile and packaged for one-time use, it adheres to FDA 510(k) clearance under the classification of Class II medical devices. The device is non-magnetic and compatible with MRI environments, ensuring safe use in imaging settings.
Frequently asked questions
What is the primary use case for the Ambu aScope 4 RhinoLaryngo Slim in clinical settings?
The Ambu aScope 4 RhinoLaryngo Slim is designed for visual examination of the nasal passages and larynx, making it ideal for procedures like rhinolaryngoscopy. Its slim profile (3.0 mm outer diameter) minimizes patient discomfort, which is particularly useful in outpatient clinics, emergency settings, or portable environments where accessibility and ease of use are critical.
Is the Ambu aScope 4 RhinoLaryngo Slim reusable, or is it intended for single-use only?
The device is explicitly labeled as single-use only. It is supplied sterile and packaged for one-time use, ensuring patient safety and hygiene without the need for reprocessing.
Can this device be safely used in MRI environments, and why?
Yes, the Ambu aScope 4 RhinoLaryngo Slim is non-magnetic, which means it is compatible with MRI environments. This feature allows for safe use in imaging settings where magnetic interference could otherwise pose a risk.
What regulatory pathway was followed for the FDA clearance of this device?
The Ambu aScope 4 RhinoLaryngo Slim received FDA clearance through a 510(k) submission, classified as a Class II medical device under the Special clearance type. The device was determined to be substantially equivalent to a predicate, with the Ear, Nose, and Throat (EN) advisory committee overseeing the review process.
How should the Ambu aScope 4 RhinoLaryngo Slim be stored to maintain its sterility?
Since the device is supplied sterile and intended for single-use, it should be stored in its original, unopened packaging until use. Proper storage conditions—such as avoiding extreme temperatures, moisture, or contamination—are essential to preserve sterility and functionality until the time of 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: Ambu® aScope™ 4 RhinoLaryngo Slim single-use endoscope, Ambu® aScope™ 4 RhinoLaryngo Slim - ENT Single-Use Rhino Laryngoscope, Ambu ENT and otorhinolaryngology products
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191080 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K191080 24 fields · synced Sep 19, 2026