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

    IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES

    K Number: K905285 · Decision Feb 11, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    16
    Applicant Total
    10
    Review Days
    77

    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
    IFSA STERILE BRAIDED POLY NONABSOR SURG SUTURES
    K Number
    K905285
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Internacional Farmaceutica, S.A. DE C.V.
    Date Received
    November 26, 1990
    Decision Date
    February 11, 1991
    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.

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

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

    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
    View all

    Other Clearances by Internacional Farmaceutica, S.A. DE C.V.

    K Number Device Name
    K072859 ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES
    K072863 ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES
    K041048 POLYDIOXANONE SYNTHETIC ABSORBABLE SURGICAL SUTURE
    K040282 ATRAMAT AND SORB-FAST POLYGLYCOLIC ACID
    K913185 STERILE STAINLESS STEEL MONOFIL NONABSORB SURG SUT
    K911354 STERILE PLAIN GUT/CHROMIC GUT ABSORB SURG SUTURES
    K911189 STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
    K905287 IFSA STERILE SILK BRAIDED NONABSOR SURG SUTURES
    K905286 IFSA STERILE NLYLON MONOFIL NONABSOR SURG SUTURES