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

    MODIFIED PGL ABSORBABLE STAPLE*

    K Number: K900069 · Decision Apr 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    315
    Registration Numbers
    315
    Same Product Code
    9
    Applicant Total
    218
    Review Days
    102

    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
    MODIFIED PGL ABSORBABLE STAPLE*
    K Number
    K900069
    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
    January 4, 1990
    Decision Date
    April 16, 1990
    Product Code
    GDG
    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
    GDG Hook, Surgical, General & Plastic Surgery

    Similar 510(k) Clearances

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

    SKIN HOOKS, VARIOUS TYPES

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

    RAYLOR(TM) DISSECTING HOOK

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

    BRIMFIELD CANNULATED GRASPING HOOKS

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

    SURGICAL HOOKS, VARIOUS

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

    SURGICAL RETRACTOR & ELASTIC STAYS, DISP

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

    MIDDLE EAR PICKS, HOOKS CURETTES,

    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 →