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

    INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR

    K Number: K940428 · Decision Apr 25, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    6
    Review Days
    84

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    Basic Information

    Device Name
    INNERDYNE SINGLE-STICK RADIALLY EXPANDING DILATOR
    K Number
    K940428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Innerdyne Medical, Inc.
    Date Received
    January 31, 1994
    Decision Date
    April 25, 1994
    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
    K940232 INNERDYNE STEP TROCAR EXPANDABLE PORT, S.T.E.P.
    K932692 INNERDYNE MEDICAL LAPAROSCOPIC SPHINCTEROTOMY KIT
    K931489 INTHERM RADIALLY EXPANDING DILATING INTRODUCER