FDA grants 510(k) clearance to Zenflow single-use cystoscope

The FDA has granted 510(k) clearance to the Zenflow Spring Scope & Camera Control Unit, the first single-use cystoscope of its kind, according to a news release from Zenflow.¹

The device features a 12 French working channel, the largest of any flexible single-use cystoscope, enabling improved visualization during flexible cystoscopy.

“This new cystoscope technology delivers clear imaging while also allowing us to provide advanced diagnostics and therapeutics in the comfort of our office,” said Bilal I. Chughtai, MD, chief of urology at Plainview Hospital in New York, in the news release.¹ “It’s an exciting and much-anticipated innovation in the field.”

In addition to the Spring Scope, the Zenflow Spring platform also includes the investigational Spring Implant and Delivery system. This product is not currently FDA approved.

The Zenflow Spring System has been assessed in the ZEST pilot studies in patients with benign prostatic hyperplasia (BPH). An analysis of these studies, which were presented at the 2025 American Urological Association Annual Meeting in Las Vegas, Nevada,² included 3 clinical trials of the system across 4 countries: Mexico, Australia, New Zealand, and Canada.

Overall, data showed long-term benefits of the system at 3 years following device placement. Specifically, patients demonstrated a 46% improvement in International Prostate Symptom Score (IPSS) from baseline to 36 months (11.8 vs 22.0). Further, IPSS quality-of-life (QOL) scores, which measure the negative impact of BPH symptoms on QOL, improved from 4.49 at baseline to 2.23 at the 36-month timepoint.

There also appeared to be no negative impact on erectile or ejaculatory function through 36 months.

Building on the ZEST studies, the device is also under investigation in the pivotal, prospective, randomized BREEZE trial (NCT04987138), which enrolled more than 200 participants through clinical trial sites in the US and Canada. Patients will be randomly assigned 2:1 to receive the Zenflow device or a sham procedure. Completion of the trial is expected in June 2026.³

“We’re thrilled to receive FDA clearance for Zenflow’s first product,” concluded Shreya Mehta, CEO of Zenflow, in the news release.¹ “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

1. Zenflow receives FDA 510(k) clearance for first-of-its-kind single-use cystoscope. News release. Zenflow. September 30, 2025. Accessed September 30, 2025. 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

2. Elterman D, Gilling P, Chin P, et al. 36-month outcomes from the ZEST pilot studies of the Zenflow Spring System for the treatment of benign prostatic hyperplasia (BPH). J Urol. 2025;213(5S):e277. doi:10.1097/01.JU.0001109800.53897.68.12

3. Safety and effectiveness study of the Zenflow Spring System (BREEZE). ClinicalTrials.gov. Updated April 11, 2024. Accessed September 30, 2025. https://clinicaltrials.gov/study/NCT04987138