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

    NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES

    K Number: K990952 · Decision Apr 1, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    218
    Review Days
    10

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    Basic Information

    Device Name
    NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES
    K Number
    K990952
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    March 22, 1999
    Decision Date
    April 1, 1999
    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

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    Other Clearances by United States Surgical, A Division of Tyco Healthc

    K Number Device Name
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    K061288 AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K062850 AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS
    K062326 AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE
    K061095 AUTO SUTUR ENDO GIA STAPLERS
    K050947 MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE
    K042412 MODIFIED SPACEMAKER SYSTEM
    K040594 HERCULON SOFT TISSUE REATTACHMENT SYSTEM
    K032696 AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT
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