Asurys Fluid Management System (Boston Scientific): FDA status

Approved Approved Mar 30, 2026. Indication: irrigation and intrarenal pressure management during urologic endoscopic procedures (ureteroscopy, cystoscopy, PCNL, BPH). Company: Boston Scientific.

Regulatory history

• Mar 30, 2026: 510(k) clearance. FDA granted 510k clearance for system that automatically adjusts irrigation flow based on real time intrarenal pressure readings urologytimes.com

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