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

    DISPOSABLE PRE-GELLED ELECTROSURGICAL

    K Number: K800557 · Decision Apr 21, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    823
    Registration Numbers
    823
    Same Product Code
    2306
    Applicant Total
    10
    Review Days
    40

    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
    DISPOSABLE PRE-GELLED ELECTROSURGICAL
    K Number
    K800557
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Vxtra Corp.
    Date Received
    March 12, 1980
    Decision Date
    April 21, 1980
    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 Vxtra Corp.

    K Number Device Name
    K832938 OCUTOME PARATUBING SET
    K832980 VXTRA OCUTOME KIT
    K831266 MICROSURGICAL KNIFE
    K830385 IRRIGATION/ASPIRATION KIT
    K830379 PHAKO KIT
    K812620 ADJUSTABLE MICROSURGICAL KNIFE
    K812526 MICRO BLADE II
    K812160 MICROSURGICAL BLADE
    K792436 VXTRA BACK PACK EKG ELECTRODE CAT. NO.