MIRA Surgical System
Surgical robotMiniaturized robotic-assisted surgery system of about 2 lb (under 1 kg), shipped sterilized in a tray and inserted through a single port with no docking or draping.
hardwareManufacturer
Pricing envelope
—Not statedapplicationsgeneral_surgery · gynecologic_surgery
inferred
“minimally invasive benign (sub-) total hysterectomy with or without salpingectomy”https://virtualincision.com/safety-information/retrieved 2026-09-28 · inferred
“mobilization of the colon during minimally invasive colectomy”https://virtualincision.com/safety-information/retrieved 2026-09-28 · inferred
Certifications
fda_de_novoFDA De Novo
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“The device was submitted via the FDA's De Novo Classification process”https://virtualincision.com/virtual-incision-receives-fda-authorization-for-the-mira-surgical-system-as-the-first-miniaturized-robotic-assisted-surgery-device/retrieved 2026-09-28 · extracted
“marketing authorization of the MIRA™ Surgical System (MIRA), the world's first miniaturized robotic-assisted surgery (miniRAS) device, for use in adults undergoing colectomy procedures”https://virtualincision.com/virtual-incision-receives-fda-authorization-for-the-mira-surgical-system-as-the-first-miniaturized-robotic-assisted-surgery-device/retrieved 2026-09-28 · extracted
fda_510kFDA 510(k)
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“the U.S. Food and Drug Administration has granted 510(k) clearance for the use of MIRA in benign hysterectomy procedures”https://virtualincision.com/virtual-incision-receives-fda-510k-clearance-for-the-mira-surgical-system-in-benign-hysterectomy-procedures/retrieved 2026-09-28 · extracted