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

    RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture

    K Number: K203081 · Decision Nov 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    16
    Applicant Total
    8
    Review Days
    42

    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
    RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
    K Number
    K203081
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lsi Solutions
    Date Received
    October 13, 2020
    Decision Date
    November 24, 2020
    Product Code
    GAS
    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
    GAS Suture, Nonabsorbable, Synthetic, Polyester

    Similar 510(k) Clearances

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

    RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene

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

    ARTHREX BIOWIRE

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

    MR-III

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

    SUTURE CORD

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

    BRAIDED POLYESTER SUTURE MATERIAL

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

    PETERS CARDIOFLON(TM) SUTURE

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

    Other Clearances by Lsi Solutions

    K Number Device Name
    K163639 LS-5 ePTFE Suture
    K040232 LSI SEW-RIGHT R SERIES SUTURE PLACEMENT DEVICE AND ACCESS PRODUCT SEW-RIGHT SR-5R, MODEL 020999
    K031443 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS
    K024301 LSI ENDOSCOPIC EXTERNAL ACCESSORY CHANNEL AND ACCESSORIES PRODUCT
    K011016 LSI SOLUTIONS FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES PRODUCT
    K981531 SUTURE PLACEMENT DEVICE AND ACCESSORIES
    K963919 LSI VIDEOSCOPIC DISPLAY SYSTEM