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

    LOOK COLLAGEN SPACERS, MODEL 1514B

    K Number: K001765 · Decision Sep 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    35
    Registration Numbers
    35
    Same Product Code
    150
    Applicant Total
    22
    Review Days
    87

    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
    LOOK COLLAGEN SPACERS, MODEL 1514B
    K Number
    K001765
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5730
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Surgical Specialties Corp
    Date Received
    June 12, 2000
    Decision Date
    September 7, 2000
    Product Code
    KXK
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KXK Source, Brachytherapy, Radionuclide

    Similar 510(k) Clearances

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

    OncoPatch

    FDA 510(k)
    FDA Class 2 ·Radiology

    IsoSphere

    FDA 510(k)
    FDA Class 2 ·Radiology

    RadianceTx Radionuclide Brachytherapy Source

    FDA 510(k)
    FDA Class 2 ·Radiology

    GammaTile

    FDA 510(k)
    FDA Class 2 ·Radiology

    Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles

    FDA 510(k)
    FDA Class 2 ·Radiology

    LV Liberty Vision Model 1 90Yttrium Brachytherapy Source

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

    Other Clearances by Surgical Specialties Corp

    K Number Device Name
    K141625 POLYSYN SURGICAL SUTURE
    K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    K140227 MONODERM SURGICAL SUTURE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K052962 OPTIMIZED BARB DESIGN
    Search all 22 clearances from Surgical Specialties Corp →