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

    NYLON NONABSORBABLE SURGICAL SUTURES, USP

    K Number: K000539 · Decision Apr 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    114
    Registration Numbers
    114
    Same Product Code
    56
    Applicant Total
    7
    Review Days
    70

    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
    NYLON NONABSORBABLE SURGICAL SUTURES, USP
    K Number
    K000539
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5020
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Arc Medical Supplies (Beijing) Co, Ltd.
    Date Received
    February 17, 2000
    Decision Date
    April 27, 2000
    Product Code
    GAR
    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
    GAR Suture, Nonabsorbable, Synthetic, Polyamide

    Similar 510(k) Clearances

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

    Tissue Approximation System

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

    Tissue Approximation System (TAS)

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

    Golnit Nylon Monofilament Suture

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

    Non Absorbable Surgical Nylon Suture

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

    Crownjun Nylon Suture

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

    REXLON, REXSIL

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

    Other Clearances by Arc Medical Supplies (Beijing) Co, Ltd.

    K Number Device Name
    K022666 PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K022664 PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P.
    K000542 PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP
    K000541 SILK NONABSORBABLE SURGICAL SUTURES, USP
    K000540 POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
    K000537 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP