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510(k) Data Aggregation

    K Number
    K972072
    Device Name
    SURGITRON MODEL FFPF-EMC
    Manufacturer
    ELLMAN INTL., INC.
    Date Cleared
    1997-06-19

    (16 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SURGITRON MODEL FFPF-EMC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Indication For Use is idendical to the Surgitron as a preammendment device such as:

    • Culling
      Skin Incisions. Biopsy. Cysts. Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps. SkinTags, Envi, Keratusis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection.

    • Blended Curring and Coagulation Skin Tags, Papilloma Kelvido, Keratosis, Verrucac, Dasal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmenc Repairs, Cysts, Absecsses, Development of Skin Flaps, Oculoplastic Procedures

    • Ilemostasıs Control of Blocding, Epilation, Telangectasia

    • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Vernicae, Hemostasis.

    • Bipolar Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry).

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Surgitron Model: FFPF-EMC". This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    The letter primarily:

    • Acknowledges receipt and review of the 510(k) notification.
    • States that the device is substantially equivalent to legally marketed predicate devices.
    • Grants permission to market the device subject to general controls and FDA regulations.
    • Lists the intended uses for the device, which are all surgical procedures (cutting, blended cutting and coagulation, hemostasis, fulguration, and bipolar coagulation).

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

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