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

    POLYVIOLENE SURGICL SUTURE

    K Number: K943949 · Decision Nov 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    25
    Review Days
    100

    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
    POLYVIOLENE SURGICL SUTURE
    K Number
    K943949
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Look, Inc.
    Date Received
    August 2, 1994
    Decision Date
    November 10, 1994
    Product Code
    GAT
    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
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

    Similar 510(k) Clearances

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

    Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

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

    HyperSuture All Green Extension Line

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

    Meniscus Versaflex

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

    Pre-Sutured Tendon

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

    ProZip Knotless Implant

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

    PowerKnot High Strength Sutures

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

    Other Clearances by Look, Inc.

    K Number Device Name
    K933686 LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE
    K926586 REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES
    K926587 REVISED LABELING FOR NYLON SUTURE (POLYAMIDE)
    K926167 POLYVIOLENE SUTURE-REVISED LABELING
    K926588 REVISED LABELING FOR POLYPROPYLENE SUTURE
    K926168 SILK SUTURES-REVISED LABELING
    K913530 LOOK VISCODISSECTOR
    K903029 STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE
    K903584 POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES
    K904054 POLYVIOLENE(TM) SUTURE
    Search all 25 clearances from Look, Inc. →