BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)

    K Number: K861807 · Decision May 23, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    182
    Registration Numbers
    182
    Same Product Code
    14
    Applicant Total
    5
    Review Days
    14

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    Basic Information

    Device Name
    MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
    K Number
    K861807
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Medcomp Technologies, Inc.
    Date Received
    May 9, 1986
    Decision Date
    May 23, 1986
    Product Code
    HRQ
    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
    HRQ Hemostat

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HRQ), ordered by most recent decision date.

    DISPOSABLE HEMOSTATS

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    BERNARD VESSEL APPROXIMATOR

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    SURGICAL HEMOSTATS

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    FDA Class 1 ·General, Plastic Surgery

    SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)

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    FDA Class 1 ·General, Plastic Surgery

    SURGICAL INSTRUMENTS

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    FDA Class 1 ·General, Plastic Surgery

    HEMSTATS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Medcomp Technologies, Inc.

    K Number Device Name
    K861805 MEDCARE FORCEPS (THUMB, TISSUE)
    K861804 MEDCARE SUTURE REMOVAL KIT
    K861806 MEDCARE SUTURE SCISSORS (SUTURE/GAUZE WEIGHT)
    K860683 MEDCARE EMERGENCY SHEARS/PUNCH & FIN TIPS