BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    AUTO SUTURE DISPOSABLE SURGICAL TROCAR*

    K Number: K890818 · Decision May 4, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    257
    Registration Numbers
    257
    Same Product Code
    51
    Applicant Total
    218
    Review Days
    76

    Basic Information

    Device Name
    AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
    K Number
    K890818
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Received
    February 17, 1989
    Decision Date
    May 4, 1989
    Product Code
    FZT
    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
    FZT Cutter, Surgical

    Similar 510(k) Clearances

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

    SMARTSHEARS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MICRINS SURGICAL SCISSOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SINGLE HAIR TRANSPLANT GRAFT

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SPC DISPOSABLE CUTTER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SCISSORS, VARIOUS

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SURGICAL SCISSORS, SET OF 3

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC

    K Number Device Name
    K071406 AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER
    K071920 AUTOSUTURE ABSORBABLE TACK AND APPLICATOR
    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
    Search all 218 clearances from UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC →