Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K171039
    Device Name
    Assut Filbloc Permanent Sutures
    Manufacturer
    Assut Europe S.p.A.
    Date Cleared
    2017-08-29

    (145 days)

    Product Code
    GAW
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Assut Europe S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FilBloc Permanent sutures are intended for general soft tissue approximation, excluding closure of the epidermis, where use of a non-absorbable suture is appropriate.
    Device Description
    The Assut FilBloc Permanent Suture range of devices comprises a variety of gauge sizes and lengths, supplied with or without stainless steel needles, which are also available in a variety of different sizes and shapes. The sutures may have a 'block' at one end, which allows surgeons to close wounds quickly and securely without tying knots or changing suturing techniques. The block is made from the same material as the suture, and is used to anchor the suture. Assut FilBloc Permanent Sutures contact the patient and remain attached to the patient at the point suturing and may remain in place for significant periods. The sutures with needles do not need to be used with any other devices, but the needleless sutures need to be used together with legally available separate needles.
    Ask a Question
    K Number
    K150553
    Device Name
    Filbloc
    Manufacturer
    ASSUT EUROPE
    Date Cleared
    2016-05-19

    (442 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASSUT EUROPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Filbloc sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    Filbloc (polydioxanone) monofilament synthetic absorbable sutures are prepared from the polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is: -(0-CH2-CH2-O-CH2-CO-CH2-CO)n- Filbloc sutures are undyed or dyed with D&C Violet No. 2 (21CFR§ 74.3602). The device is designed with unidirectional or bidirectional barbs, or with unidirectional barbs and final block in PDO. The barbs and the block design allow for tissue approximation, without need to tie surgical knot. The device is available in various lengths and diameter sizes 2 through 4/0 with various needles attached at one end or to both ends.
    Ask a Question
    K Number
    K021767
    Device Name
    ASSUFIL
    Manufacturer
    ASSUT EUROPE S.P.A.
    Date Cleared
    2002-11-19

    (174 days)

    Product Code
    GAM
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASSUT EUROPE S

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Assufil It is advised when an absorbable suture is needed for use in General Soft Tissue Approximation and Ligation
    Device Description
    absorbable surgical suture
    Ask a Question

    Page 1 of 1