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

    JARIT HULKA UTERINE TENACULUM FORCEPS

    K Number: K082349 · Decision Nov 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    19
    Applicant Total
    11
    Review Days
    98

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    Basic Information

    Device Name
    JARIT HULKA UTERINE TENACULUM FORCEPS
    K Number
    K082349
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J. Jamner Surgical Instruments, Inc.
    Date Received
    August 15, 2008
    Decision Date
    November 21, 2008
    Product Code
    HDC
    Advisory Committee
    Obstetrics/Gynecology
    Review Advisory Committee
    OB
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HDC Tenaculum, Uterine

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    Other Clearances by J. Jamner Surgical Instruments, Inc.

    K Number Device Name
    K944670 JARIT RECOMMENDED SINUS INSTRUMENTS
    K944870 JARIT ENDOSCOPES, MODELS 600-600; 600-630; 600-650; AND 600-680
    K941565 JARIT RECOMMENDED SINUS INSTRUMENTS
    K932456 JARIT SURGICAL INSTRUMENTS
    K933728 JARIT SURGICAL INSTRUMENTS: CATALOG 615-330, 615-331, 615-334, 615-335, 615-338, 615-339
    K931928 JARIT SURGICAL INSTRUMENTS
    K931959 JARIT SURGICAL INSTRUMENTS
    K931878 JARIT ENDOSCOPES, 600-600; 600-630; 600-650; 680
    K771625 LEININGEO AORTIC PUNCH #310-395 & 397
    K771624 COPE LUNG FORCEPS #305-218
    Search all 11 clearances from J. Jamner Surgical Instruments, Inc. →