Ambu A/S · Class II · Cleared Jun 11, 2025
| K-number | K250269 |
| Device name | Ambu® aScope 5 Cysto HD (Standard Deflection); Ambu® aScope 5 Cysto HD (Reverse Deflection) |
| Applicant | Ambu A/S |
| Product code | FAJ |
| Device class | Class II |
| Decision date | Jun 11, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 876.1500 |
The Ambu aScope 5 Cysto HD is a sterile, single-use flexible cysto-nephroscope designed for endoscopic examination of the lower urinary tract and kidney. It connects to a compatible Ambu display unit (aBox 2 or aView 2 Advance) to provide visualization and can be used with endoscopic instruments and accessories for fluid instillation and suctioning.
Both the Ambu aScope 5 Cysto HD and predicate device control the distal end via a handle button, have a working channel with one inlet and outlet, include a distal-tip camera, and connect to a compatible monitor. The Ambu device differs in insertion portion diameter and is single-use rather than reusable, but these differences do not introduce safety or performance issues.
ISO 8600-3 (optical performance), IEC 62471 (photobiological safety), ASTM D4169 (transportation), ISO 11135 (sterilization validation), ASTM F1980 (shelf-life stability), ISO 10993-1 (biocompatibility), IEC 60601-1 and IEC 60601-2-18 (electrical safety), and IEC 60601-1-2 (electromagnetic compatibility).
The device shares the same indications for use and core technological mechanisms as the predicate (VISERA CYSTO-NEPHRO VIDEOSCOPE). Although the Ambu device has a different insertion diameter and is single-use rather than reusable, comprehensive verification and optical performance testing, along with biocompatibility and safety testing, demonstrate it performs as intended and meets predefined specifications equivalent to the predicate without introducing new safety concerns.
View the full FDA submission: accessdata.fda.gov