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

    TROCAR SLEEVE

    K Number: K931561 · Decision Feb 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    337
    Applicant Total
    14
    Review Days
    314

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    Basic Information

    Device Name
    TROCAR SLEEVE
    K Number
    K931561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    884.1720
    Medical Specialty
    Obstetrics/Gynecology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    L.A.S.E.R., Inc.
    Date Received
    March 30, 1993
    Decision Date
    February 7, 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 L.A.S.E.R., Inc.

    K Number Device Name
    K983965 CO2 LASER COUPLER
    K950021 REUSABLE TROCAR WITH SAFETY SLEEVE
    K940454 GRASPING FORCEPS, PUNCHES, SCISSORS
    K933421 ENDOSCOPIC INSTRUMENTS AND ACCESSDORIES
    K924844 BULK TISSUE REMOVAL SYSTEM
    K932045 DISPOSABLE INSUFFLATION TUBING
    K931092 ENDOSCOPIC RETRACTOR
    K914197 ALLOY SCALPEL HANDPIECES
    K904638 TROCAR DISPOSABLE
    K892912 MODEL JM-1 CO2 LASER
    Search all 14 clearances from L.A.S.E.R., Inc. →