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

    DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX

    K Number: K070997 · Decision May 16, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    4
    Review Days
    37

    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
    DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE CABLES, MODEL 5015-XX
    K Number
    K070997
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pro-Med Instruments GmbH
    Date Received
    April 9, 2007
    Decision Date
    May 16, 2007
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

    Similar 510(k) Clearances

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

    Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    CoolSeal Generator® (CSL-200-90)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NEUROMARK System (NMK00301)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LAP-iX2N

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    OsteoCool™ RF Ablation System; OsteoCool™ 2.0 RF Ablation System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MILAN System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Pro-Med Instruments GmbH

    K Number Device Name
    K063494 DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS
    K032331 DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)
    K001808 DORO HEADREST SYSTEM