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

    SURGICAL KNIVES & PROBES

    K Number: K843497 · Decision Oct 31, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    20
    Applicant Total
    10
    Review Days
    55

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SURGICAL KNIVES & PROBES
    K Number
    K843497
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Eder Instrument Co, Inc.
    Date Received
    September 6, 1984
    Decision Date
    October 31, 1984
    Product Code
    EMF
    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
    EMF Knife, Surgical

    Similar 510(k) Clearances

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

    MOUNTABLE ENDOSCOPIC BLADE

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

    MOUNTABLE ENDOSCOPIC KNIFE

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

    MICROSURGICAL KNIVES

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

    MICROSURGERY RAZOR BLADE HOLDER

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

    MICROSURGICAL SCARIFIER

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

    VAN-TEC ENDOPYELOTOMY KNIFE

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

    Other Clearances by Eder Instrument Co, Inc.

    K Number Device Name
    K843498 BIPOLAR SUCTION ELECTRODE
    K843499 ARTHROSCOPY LEG HOLDER
    K831255 LARYNGOSCOPE ATTACHMENT PH2000
    K831240 LASER BRONCHOSCOPE
    K831241 LASER LAPARAXOPE
    K822959 ENDOSCOPIC VIDEOSYSTEM
    K802479 SURGICAL KNIVES & PROBES
    K792100 GRASPING FORCEP (W/FOUR PRONGS)
    K791052 ENDOSCOPIC INSTRUMENT