Bendit Technologies is proud to announce that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Bendit17 Microcatheter, the smallest steerable microcatheter on the market. This milestone marks a significant step forward in advancing precision and accessibility in neurovascular and peripheral endovascular interventions.
The FDA clearance enables Bendit to bring its innovative technology to physicians and patients across the United States. The company is in the final stages of production and preparing to initiate its first U.S. commercial clinical procedures beginning in January 2026. In parallel, Bendit is actively pursuing additional regulatory clearances in other global territories.
Oz Cabiri, CEO of Bendit Technologies said: “FDA clearance of the Bendit17 is a major milestone for our team and a meaningful advancement for clinicians seeking greater control and navigational precision in complex vascular procedures.
“The device’s capability to navigate with or without a guidewire represents a significant technological leap forward. Our mission is to push the boundaries of what is possible in endovascular care, and the Bendit17 embodies that vision. We look forward to bringing this technology available to physicians in the U.S. and supporting improved care for patients worldwide.”
The company says the Bendit17 Microcatheter introduces ‘a new level’ of steerability and precision, enabling controlled navigation through complex anatomies while maintaining stability, control, and ease of use, with its capabilities being ‘uniquely’ designed to support clinicians across a broad range of intricate vascular procedures.
