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510(k) Data Aggregation

    K Number
    K252287

    Validate with FDA (Live)

    Device Name
    Symani Surgical System
    Manufacturer
    Medical Microinstruments, Inc.
    Date Cleared
    2025-11-10

    (110 days)

    Product Code
    SAQ
    Regulation Number
    878.4963
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K242368
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Symani® Surgical System is indicated for soft tissue manipulation in open microsurgical procedures to perform:

    • Anastomosis, suturing, and ligation microsurgery techniques on small blood vessels and lymphatic ducts between 0.1 and 2.5mm in open free-flap surgery of the breast, mouth, scalp, and extremities and in open lymphatic surgery of the extremities.
    • Dissection of soft tissues.
    Device Description

    Symani is designed to provide surgeons with increased precision while leveraging the surgeon's own surgical experiences. The Symani Surgical System consists of three components, the CMM, Console, and Instruments, with selectable scaling factors between 7x to 20x to improve motion control and scale down any physiological tremor of the operator in a similar fashion to conventional robotic-assisted surgical device (RASD) systems, and the instruments with wristed end-effectors to improve dexterity for tissue manipulation and suturing. The subject device has the same intended use as the predicate device, K242358. Subject device includes two new NanoWrist instruments, Scissors and Forceps.

    AI/ML Overview

    N/A

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