Bendit Technologies said the FDA has granted 510(k) clearance for the Bendit17 Microcatheter, the smallest steerable microcatheter on the market. This marks a step forward in advancing precision and accessibility in neurovascular and peripheral endovascular interventions.
The FDA clearance enables Bendit to bring its technology to physicians and patients across the U.S. The company said it 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.
The Bendit17 Microcatheter introduces a new level of steerability, enabling controlled navigation through complex anatomies while maintaining stability, control, and ease of use. Its capabilities are designed to support clinicians across a broad range of intricate vascular procedures.
