Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242894
    Device Name
    SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD14); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD23); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD36); SanAgile™ Ultrasonic Surgery Advanced Dissector (SASD45)
    Manufacturer
    Shanghai Saints Sages Surgical Co., Ltd.
    Date Cleared
    2025-06-18

    (268 days)

    Product Code
    LFL
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shanghai Saints Sages Surgical Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SA10 Portable Controller is intended to provide power to drive SanAgile™ Ultrasonic Surgery Advanced Dissectors that are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired. SanAgile™ Ultrasonic Surgery Advanced Dissectors are indicated for vessel sealing and soft tissue incisions when bleeding control and minimal thermal injury are desired in general, sealing and transection of lymphatic vessels, and other open or laparoscopic procedures. The dissectors can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the MIN button.
    Device Description
    The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller consists of two interdependent devices: portable controller (Cat. # SA10) and single patient use dissector (Cat. #s SASD14, SASD23, SASD36 and SASD45). The SA10 Portable Controller is a compact portable generator and provides power to drive the dissectors for dissection, coagulation, and cutting tissues in open or laparoscopic procedures. The SanAgile™ Ultrasonic Surgery Advanced Dissector and Portable Controller is intended to be used by qualified medical professionals trained in the techniques and surgical procedures, such as surgeons and nurses, in hospital operation rooms. SA10 Portable Controller is also intended to be maintained by trained service or biomedical engineers and validated for cleaning and disinfection between surgeries. The Advanced Dissector is integrated with a transducer for single use; therefore, no dissector-transducer assembly is required prior to surgery.
    Ask a Question

    Page 1 of 1