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

    SUTURE PLACEMENT DEVICE AND ACCESSORIES

    K Number: K981531 · Decision Jul 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    75

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    Basic Information

    Device Name
    SUTURE PLACEMENT DEVICE AND ACCESSORIES
    K Number
    K981531
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions
    Date Received
    April 29, 1998
    Decision Date
    July 13, 1998
    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 Lsi Solutions

    K Number Device Name
    K203081 RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
    K163639 LS-5 ePTFE Suture
    K040232 LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
    K031443 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
    K024301 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
    K011016 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
    K963919 LSI VIDEOSCOPIC DISPLAY SYSTEM