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

    LUKENS STAINLESS STEEL SURGICAL SUTURE

    K Number: K930940 · Decision Dec 17, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    8
    Review Days
    297

    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
    LUKENS STAINLESS STEEL SURGICAL SUTURE
    K Number
    K930940
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Lukens Medical Corp.
    Date Received
    February 23, 1993
    Decision Date
    December 17, 1993
    Product Code
    GAQ
    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
    GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

    Similar 510(k) Clearances

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

    CoNextions TR Tendon Repair System

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

    Wego-Stainless Steel

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

    MERISTEEL

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

    Surgical Stainless Steel Suture, Stainless Steel Suture

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

    DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE

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

    FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP

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

    Other Clearances by Lukens Medical Corp.

    K Number Device Name
    K965162 LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.
    K930941 LUKENS POLYPROPYLENE MONOFILAMENT NONABSORBABLE
    K930942 LUKENS SILK SURGICAL SUTURE
    K930945 BRAIDED POLYESTER SURGICAL SUTURE
    K930944 LUKENS SURGICAL GUT SUTURE
    K930943 LUKENS NYLON SURGICAL SUTURE
    K904535 LU-TEX II