Ambu announced it has received expanded FDA 510(k) clearance for its aScope 5 Cysto HD, making it the first single-use flexible cysto-nephroscope cleared for use in percutaneous nephrolithotomy (PCNL) procedures in the U.S.
The clearance extends the device’s use beyond cystoscopy to include kidney stone removal procedures performed through a small incision in the back. The aScope 5 Cysto HD previously received CE mark clearance in Europe earlier this year.
Ambu’s U.S. urology portfolio now includes aScope 4 Cysto (single-use cystoscope), aScope 5 Cysto HD (cysto-nephroscope), and aScope 5 Uretero (ureteroscope). All three endoscopes are compatible with Ambu’s digital endoscopy systems, aView 2 Advance and aBox 2, which allow for streamlined imaging and device integration.
According to the company, the digital platform enables simultaneous connection and dual visualization of the aScope 5 Uretero and aScope 5 Cysto HD, offering workflow advantages for clinicians performing combined ureteroscopy and PCNL procedures.
“The FDA clearance of our cysto-nephroscopy solution underpins our commitment to expanding our innovation and leadership in urology. With three single-use endoscopes integrated into one digital platform, we offer a leading portfolio that enables clinicians to efficiently perform a broad range of urology procedures, advancing the standard of care for patients,” CEO Britt Meelby Jensen said in a news release.
