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

Reno, Nevada (UroToday.com) -- 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.

Flexible cystoscopy is the most common office-based procedure performed by urologists and is essential for diagnosing and treating lower urinary tract conditions.¹ In the United States alone, approximately 1.2 million cystoscopies are performed annually, underscoring its critical role in patient care.²

Bilal Chughtai, M.D., Chief of Urology at Plainview Hospital and investigator of the Zenflow Spring System, said, “This new cystoscope technology delivers clear imaging while also allowing us to provide advanced diagnostics and therapeutics in the comfort of our office. It’s an exciting and much-anticipated innovation in the field.”

“We’re thrilled to receive FDA clearance for Zenflow’s first product,” said Shreya Mehta, CEO of Zenflow. “With advanced imaging, catheter flexibility, and a large working channel, the Spring Scope is a meaningful innovation in its own right, and a key enabler and differentiator for our forthcoming BPH therapy, the Zenflow Spring Implant and Delivery System. This progress reflects our commitment to bringing patient-focused innovation to urologists and their patients.”

References

Kim J, Gao B, Bhojani N, Zorn KC, Chughtai B, Elterman DS. Micro-cost analysis of single-use vs. reusable cystoscopy in a single-payer healthcare system. Can Urol Assoc J. 2022 Oct;16(10):346-350. doi: 10.5489/cuaj.7828. PMID: 35621291; PMCID: PMC9565074. https://pmc.ncbi.nlm.nih.gov/articles/PMC9565074/#b2-cuaj-10-346
Cystoscopy Market by Product Type (Flexible, Rigid, Single Use), Technology (3D Visualization, Digital, Fiber Optic), End User, Application - Global Forecast 2025-2032 https://www.360iresearch.com/library/intelligence/cystoscopy

Source: Zenflow, Inc. (2025). Zenflow Receives FDA 510(k) Clearance for First-of-Its-Kind Single-Use Cystoscope [Press release]. https://www.globenewswire.com/news-release/2025/09/30/3158543/0/en/Zenflow-Receives-FDA-510-k-Clearance-for-First-of-Its-Kind-Single-Use-Cystoscope.html.

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