FDA Clears Zenflow’s Spring Scope to Improve Urology Procedures

Zenflow has received FDA 510(k) clearance for its Spring Scope and Camera Control Unit (CCU), a single-use cystoscope designed to improve visualization during urology procedures. The device features a 12 French working channel, more than 80% larger than existing disposable models, providing advanced imaging, catheter flexibility, and enhanced patient comfort.

Zenflow emphasized that the Spring Scope is not only a significant standalone innovation but also a vital component of its forthcoming Spring Implant and Delivery System for treating benign prostatic hyperplasia (BPH). While the implant system remains investigational, pilot studies (ZEST) have shown sustained three-year benefits for men with BPH.

Flexible cystoscopy, one of the most common office-based procedures in urology, plays a crucial role in diagnosing and managing lower urinary tract conditions. Zenflow said its Spring System aims to establish a new treatment category—first-line interventional therapy—offering minimally invasive, reversible alternatives to medication.

01-10-2025