Hugo robotic assisted surgery system (Hugo RAS): FDA status

Approved Approved Dec 3, 2025. Indication: minimally invasive urologic procedures including prostatectomy nephrectomy and cystectomy. Company: Medtronic.

Regulatory history

• Dec 3, 2025: 510(k) clearance. FDA cleared the Hugo robotic assisted surgery system for urologic surgical procedures based on the Expand URO IDE study urologytimes.com

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