BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY

    K Number: K083428 · Decision Sep 1, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    20
    Registration Numbers
    20
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    286

    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
    F7244, F7255, F7266, F7277, F7288, F7233, F7234 SERIES OF BATTERY-POWERED CAUTERY
    K Number
    K083428
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4115
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Fiab Spa
    Date Received
    November 19, 2008
    Decision Date
    September 1, 2009
    Product Code
    HQP
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQP Unit, Cautery, Thermal, Battery-Powered

    Similar 510(k) Clearances

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

    CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    KIRWAN DISPOSABLE BATTERY-POWERED CAUTERY, MODEL 41-61XX SERIES

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SURGICAL MEDICAL DEVICE CAUTERY

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    STARION INSTRUMENTS POWER POINT CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAUTERY GRASPER/DISSECTOR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    THERMAL CAUTERY DEVICE, FORCEPS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Fiab Spa

    K Number Device Name
    K192210 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    K180047 ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System
    K123361 ESOTEST ESOPHAGEAL TEMPERATURE PROBE AND TEMPERATURE MONITORING SYSTEM
    K103783 EURO DEFI PADS ADULT; EURO DEFI PADS ADULT RADIOTRANSPARENT: EURO DEFI PADS PEDIATRIC
    K100333 FIAB SPA, MODELS F7244, F7233, F7234, F7277
    K091163 PG471W , PG471/50W, PG474W, PG477W, PG479/32W, PG479/50W, PG479/75W FIAB DISPOSABLE ELECTRODES WITH CABLE FOR ELECTRO-ST