Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope
Spring® Scope delivers the largest working channel of any flexible single-use cystoscope, enhancing visualization and patient comfort
SOUTH SAN FRANCISCO, Calif., Sept. 30, 2025 (GLOBE NEWSWIRE) — Zenflow, Inc., a medical device company developing innovative urological solutions, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Zenflow Spring® Scope & Camera Control Unit (CCU).
The Zenflow Spring Scope is the first single-use cystoscope of its kind. Featuring a 12 French working channel – more than 80% larger than current single-use models – it enables urologists to perform procedures with improved visualization while maintaining patient comfort.