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

    NYLON COATED SPECULA

    K Number: K925501 · Decision Jun 13, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    71
    Applicant Total
    76
    Review Days
    1687

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    Basic Information

    Device Name
    NYLON COATED SPECULA
    K Number
    K925501
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.4530
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Zinnanti Surgical Instruments, Inc.
    Date Received
    October 30, 1992
    Decision Date
    June 13, 1997
    Product Code
    HIB
    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
    HIB Speculum, Vaginal, Nonmetal

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    Other Clearances by Zinnanti Surgical Instruments, Inc.

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    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
    K925959 FORCEPS FOR LAPAROSCOPIC SURGERY GU USE
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