Bendit Technologies announced today that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the Bendit17 microcatheter, which the company describes as the smallest steerable microcatheter on the market.
Bendit shares in a press release that the company is in the final stages of production and preparing to initiate its first US commercial clinical procedures beginning in January 2026. In parallel, Bendit notes that it is actively pursuing additional regulatory clearances in other global territories.
Oz Cabiri, CEO of Bendit Technologies, commented: “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 USA and supporting improved care for patients worldwide.”
Bendit outlines that 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. Its unique capabilities are designed to support clinicians across a broad range of intricate vascular procedures.
