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Anovo Sterile Drape for Robotic Control Unit, bottom

MOMENTIS SURGICAL LTD · Model - · UDI-DI 07290018151136

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510(k) clearances

Adverse events

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Facilities

Description

The AnovoTM Surgical System is a robotic-assisted device intended for use by laparoscopic trained physicians for endoscopic manipulation of tissue, using graspers and electrosurgery devices during single-site laparoscopic gynecologic procedures such as benign hysterectomy and salpingo-oophorectomy through a transvaginal access point. The system composed of Anovo Surgeon Console, two sterile instruments (Anovo Instrument ARMS), bed-mounted Robotic Control Unit (RCU) and Anovo System Accessories (Unit cables, Sterile Drapes, Robotic Control Unit Support System (RCUSS) and Vaginal Access Kit). There are two (2) sterile surgical drapes which separate the Anovo Robotic Control Units from the sterile field and maintains sterility – the Bottom Drape and Top Drape. Since the Robotic Control Units are fastened together, they are covered together as well.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.