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

    ENDOSCOPIC HEMOSTATIC LIGATING LOOP

    K Number: K902731 · Decision Sep 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    29
    Applicant Total
    218
    Review Days
    78

    Basic Information

    Device Name
    ENDOSCOPIC HEMOSTATIC LIGATING LOOP
    K Number
    K902731
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4830
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Received
    June 21, 1990
    Decision Date
    September 7, 1990
    Product Code
    GAL
    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
    GAL Suture, Absorbable, Natural

    Similar 510(k) Clearances

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

    Surgical Gut Suture

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

    DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT

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

    UNIPLAIN & UNICHROM

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

    AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE

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

    SUTURTEK FASTCLOSE SUTURING DEVICE

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

    SERRALGUT

    FDA 510(k)
    FDA Class 2 ·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 →