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

    ENDOSCOPIC RETRACTOR

    K Number: K931092 · Decision Apr 30, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    14
    Review Days
    58

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    Basic Information

    Device Name
    ENDOSCOPIC RETRACTOR
    K Number
    K931092
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    L.A.S.E.R., Inc.
    Date Received
    March 3, 1993
    Decision Date
    April 30, 1993
    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 L.A.S.E.R., Inc.

    K Number Device Name
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    K931561 TROCAR SLEEVE
    K933421 ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES
    K924844 BULK TISSUE REMOVAL SYSTEM
    K932045 DISPOSABLE INSUFFLATION TUBING
    K914197 ALLOY SCALPEL HANDPIECES
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