Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150271
    Device Name
    Prime Adaptive Ultrasonic Scalpel System
    Manufacturer
    Date Cleared
    2015-05-29

    (114 days)

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

    ENDOPRIME, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Prime™ Adaptive Ultrasonic Scalpel System is a cutting and coagulation system indicated for open, laparoscopic surgery in soft tissue where control of hemostasis and thermal spread is desired. The system is indicated for dissection, sealing, transection, otomy creation and transection/coagulation of vessels as indicated for each cutting and coagulation instrument used (consult the instructions for use provided with each instrument). The system can be used as an adjunct to, or substitute for electro-surgery, lasers, or steel scalpels.
    Device Description
    The Prime™ Adaptive Ultrasonic Scalpel System has three major components: Generator (with footswitch), Transducer Handpiece and instruments (or blades). The Prime™ 6000 Generator provides input/output control and operation interface to automatically adapt the ultrasonic power output for the tissue load encountered.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1