Ambu aScope Gastro, Ambu aBox 2
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K212382 FDA 510(k)
- FDA Product Code
- FDS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ambu aScope Gastro is a flexible gastroscope, designed for single-use endoscopic examination of the upper gastrointestinal tract. It provides sterile, disposable access for visual inspection of the esophagus, stomach, and duodenum, ensuring consistent performance and reduced risk of cross-contamination. The device is categorized under flexible endoscopes and is intended for use in gastroenterology procedures.
Supplied as a sterile, single-use device, the Ambu aScope Gastro is paired with the Ambu aBox 2—a full HD display and processing unit featuring a built-in touchscreen, processor, and recorder. The system is intended for use in clinical settings, adhering to FDA 510(k) clearance (K212382) under the Gastroenterology and Urology advisory committees. The aBox 2 supports plug-and-play connectivity with the aScope Gastro, enabling real-time imaging and documentation. No MRI safety information is specified.
Frequently asked questions
What is the primary use case for the Ambu® aScope™ Gastro in clinical settings?
The Ambu® aScope™ Gastro is designed for single-use endoscopic examinations of the upper gastrointestinal tract, allowing sterile visualization of the esophagus, stomach, and duodenum. It is specifically intended for use in gastroenterology procedures, ensuring consistent performance and reducing the risk of cross-contamination by eliminating the need for reprocessing.
How is the Ambu® aScope™ Gastro supplied, and what does this mean for infection control?
The Ambu® aScope™ Gastro is supplied as a sterile, single-use device, which means each scope is packaged for one-time use only. This design eliminates the need for cleaning, disinfection, or sterilization between patients, thereby significantly lowering the risk of cross-contamination and improving infection control in clinical settings.
What is the role of the Ambu® aBox™ 2 in this system, and how does it integrate with the aScope™ Gastro?
The Ambu® aBox™ 2 is a full HD display and processing unit that pairs with the Ambu® aScope™ Gastro to provide real-time imaging, documentation, and recording capabilities. It features a built-in touchscreen, processor, and recorder, enabling plug-and-play connectivity for seamless integration during endoscopic procedures.
Are there different sizes or models available for the Ambu® aScope™ Gastro, and if so, how would I determine the right fit?
The provided data does not specify distinct sizes or models for the Ambu® aScope™ Gastro, but it is categorized under flexible gastroscopes. Selection should be based on clinical needs and patient-specific factors, such as the flexibility required for the procedure and patient anatomy. Consulting the manufacturer’s guidelines or a sales representative would be advisable for precise recommendations.
What storage requirements apply to the Ambu® aScope™ Gastro before use, and how should it be handled?
Since the Ambu® aScope™ Gastro is a sterile, single-use device, it should be stored in its original, unopened packaging until ready for use. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and functionality. Always follow the manufacturer’s instructions for storage and handling to ensure optimal performance.
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 gastroenterology products, Ambu aScope Gastro | Single-use gastroscopy | Ambu, Ambu Gastroenterology Products - ambuusa.com, Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 (K232919) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212382 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K212382 24 fields · synced Sep 19, 2026