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

    MAHE INSTRUMENTS

    K Number: K935442 · Decision Mar 14, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    8
    Review Days
    122

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    Basic Information

    Device Name
    MAHE INSTRUMENTS
    K Number
    K935442
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mahe-Medizintechnik
    Date Received
    November 12, 1993
    Decision Date
    March 14, 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 Mahe-Medizintechnik

    K Number Device Name
    K942821 MAHE INSTRUMENTS
    K942819 TROCAR WITH SHIELD
    K933768 COAGULATOR, LAPAROSCOPIC, LUNIPOLAR/ACCESSORIES
    K933767 FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY
    K933770 FORCEPS, ENT INSTR, ENT MANUAL SURG RETRACT/ALL TYPE
    K933772 PUNCH SURGICAL
    K925624 MICROSURGICAL INSTRUMENTS