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

    MICRO CAUTERY NEEDLES

    K Number: K891400 · Decision Apr 6, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    52
    Registration Numbers
    52
    Same Product Code
    35
    Applicant Total
    76
    Review Days
    23

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    Basic Information

    Device Name
    MICRO CAUTERY NEEDLES
    K Number
    K891400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Zinnanti Surgical Instruments, Inc.
    Date Received
    March 14, 1989
    Decision Date
    April 6, 1989
    Product Code
    JOS
    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
    JOS Electrode, Electrosurgical

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    K925560 ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODES
    K925957 SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USE
    K925960 FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USE
    K926021 NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE
    K925958 SCISSOR FOR LAPAROSCOPIC SURGERY GU USE
    K926181 ZSI LAPAROSCOPES-GENERAL & PLASTIC SURGERY
    K926016 NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE
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