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

    INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT

    K Number: K932692 · Decision Dec 27, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    207

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    Basic Information

    Device Name
    INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
    K Number
    K932692
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Innerdyne Medical, Inc.
    Date Received
    June 3, 1993
    Decision Date
    December 27, 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 Innerdyne Medical, Inc.

    K Number Device Name
    K943253 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
    K943056 SINGLE STICK RADIALLY EXPANDING DILATOR
    K940428 INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
    K940232 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
    K931489 INTHERM RADIALLY EXPANDING DILATING INTRODUCER