aScope 5 Uretero (Standard Deflection); aScope 5 Uretero (Reverse Deflection); aBox 2
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K233630 FDA 510(k)
- FDA Product Code
- FGB FDA 510(k)
- Models / Variants
- Ambu® aScope™ 5 Uretero (Reverse Deflection) FDA 510(k)Ambu® aBox™ 2 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 aScope 5 Uretero is a flexible ureteroscope designed for diagnostic and therapeutic procedures within the urinary tract. It provides high-definition imaging and two deflection options—standard and reverse—to enhance maneuverability during ureteroscopy, enabling visualization and intervention in complex anatomical regions. Classified as a ureteroscope and accessories, this device supports minimally invasive urological assessments and treatments, including stone removal, biopsy, and stent placement.
Supplied as a single-use device, the aScope 5 Uretero is intended for use in sterile operating room environments, adhering to standard surgical protocols. It is paired with the aBox 2 control unit for operation and is not MRI-compatible. The system is FDA-cleared under 510(k) K233630, with a classification of Class II. Devices are packaged for one-time use, requiring proper disposal post-procedure to maintain sterility and regulatory compliance.
Frequently asked questions
What is the Ambu aScope 5 Uretero used for?
The Ambu aScope 5 Uretero is designed for diagnostic and therapeutic procedures within the urinary tract. Its high-definition imaging and dual deflection options—standard and reverse—enhance maneuverability, enabling visualization and intervention in complex anatomical regions. Common applications include stone removal, biopsy, and stent placement during ureteroscopy.
How is the Ambu aScope 5 Uretero supplied and intended for use?
The device is supplied as a single-use, sterile ureteroscope intended exclusively for sterile operating room environments. It must be used in compliance with standard surgical protocols and disposed of immediately after use to maintain sterility and regulatory compliance. It is paired with the aBox 2 control unit for operation.
Is the Ambu aScope 5 Uretero reusable or single-use?
The Ambu aScope 5 Uretero is strictly a single-use device. This design ensures sterility and reduces the risk of cross-contamination between patients. After a single procedure, the device must be discarded according to regulatory guidelines to maintain compliance and safety.
What are the key features that distinguish the Ambu aScope 5 Uretero?
The Ambu aScope 5 Uretero stands out due to its high-definition imaging and two deflection options: standard and reverse. These features improve maneuverability in the urinary tract, making it ideal for navigating complex anatomical regions during diagnostic and therapeutic procedures. It is also paired with the aBox 2 control unit for seamless operation.
Can the Ambu aScope 5 Uretero be used with MRI equipment?
No, the Ambu aScope 5 Uretero is not MRI-compatible. This means it should not be used or stored in proximity to MRI machines, as exposure to magnetic fields could compromise the device’s integrity or safety. Always follow manufacturer guidelines for handling and storage.
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™ 5 Uretero | single-use ureteroscope | Ambu, Ambu® aScope™ 5 Uretero |single-use ureteroscope| Ambu, Ambu® aScope™ 5 Uretero - Single-Use Ureteroscope
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233630 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K233630 24 fields · synced Oct 1, 2026