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

    INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX

    K Number: K983200 · Decision Dec 11, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    321
    Registration Numbers
    322
    Same Product Code
    106
    Applicant Total
    9
    Review Days
    88

    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
    INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX
    K Number
    K983200
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ximed/Prosure/Injectx
    Date Received
    September 14, 1998
    Decision Date
    December 11, 1998
    Product Code
    GAA
    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
    GAA Needle, Aspiration And Injection, Disposable

    Similar 510(k) Clearances

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

    CapnoSpot™ Pneumothorax Decompression Indicator

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

    ARVIK LAPAROSCOPIC ASPIRATION INSTRUMENT

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

    IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

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

    PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES

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

    MANAN ACCURA NEEDLE

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

    BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4)

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

    Other Clearances by Ximed/Prosure/Injectx

    K Number Device Name
    K002269 ELECTROSURGICAL PROBES AND DEVICES-GELTX
    K994151 PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES
    K983765 INJECTION NEEDLE PROBE/DEVICE-TUNIS
    K981256 ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE
    K974484 ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE
    K974637 ELECTRODES/PROBES/DEVICES
    K962593 ELECTROSURGICAL PROBES & DEVICES
    K945995 BIPOLAR ELECTROSURGICAL PROBES AND INSTRUMENTS