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

    DYNABITE HYSTEROSCOPIC FORCEPS

    K Number: K934506 · Decision Mar 22, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    8
    Review Days
    189

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    Basic Information

    Device Name
    DYNABITE HYSTEROSCOPIC FORCEPS
    K Number
    K934506
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Portlyn Corp.
    Date Received
    September 14, 1993
    Decision Date
    March 22, 1994
    Product Code
    HET
    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
    HET Laparoscope, Gynecologic (And Accessories)

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    Other Clearances by Portlyn Corp.

    K Number Device Name
    K970083 DYNABITE HOT GI BIOPSY FORCEPS
    K951447 DYNABITE CARDIOVASCULAR BIOPSY FORCEPS
    K952391 DYNABITE UROLOGICAL FORCEPS
    K944245 DYNABITE LAPAROSCOPIC FORCEPS
    K901300 BIOPSY FORCEPS
    K896147 BIOPSY FORCEP (NON-ELECTRIC)
    K896146 BIOPSY FORCEPS, (NON-RIGID)