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

    MAHE INSTRUMENTS

    K Number: K942821 · Decision Nov 2, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    8
    Review Days
    141

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    Basic Information

    Device Name
    MAHE INSTRUMENTS
    K Number
    K942821
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mahe-Medizintechnik
    Date Received
    June 14, 1994
    Decision Date
    November 2, 1994
    Product Code
    GEI
    Advisory Committee
    General, Plastic Surgery
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by Mahe-Medizintechnik

    K Number Device Name
    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
    K935442 MAHE INSTRUMENTS
    K933772 PUNCH SURGICAL
    K925624 MICROSURGICAL INSTRUMENTS