Ambu wins FDA clearance for first single-use cysto-nephroscope

June 20, 2025
9:44 pm

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.

Ambu wins FDA clearance for first single-use cysto-nephroscope

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