BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)

    K Number: K260177 · Decision Feb 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    5
    Review Days
    22

    Basic Information

    Device Name
    Saberscope™ Laparoscope (SAS-A-536L); Xenocor® Video Processing Unit (VPUX-1)
    K Number
    K260177
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Xenocor, Inc.
    Date Received
    January 21, 2026
    Decision Date
    February 12, 2026
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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    Other Clearances by Xenocor, Inc.

    K Number Device Name
    K220872 Saberscope5 Laparoscope
    K193315 Xenocor Articulating Xenoscope Laparoscope
    K171344 Xenocor Xenoscope Laparoscopic System
    K161838 Xenocor Xenoscope Laparoscopic System