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

    SURGICAL INSTRUMENT GUIDE

    K Number: K950007 · Decision Mar 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    236
    Registration Numbers
    236
    Same Product Code
    27
    Applicant Total
    218
    Review Days
    71

    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
    SURGICAL INSTRUMENT GUIDE
    K Number
    K950007
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    United States Surgical, A Division of Tyco Healthc
    Date Received
    January 3, 1995
    Decision Date
    March 15, 1995
    Product Code
    GDF
    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
    GDF Guide, Needle, Surgical

    Similar 510(k) Clearances

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

    NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013

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

    GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE

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

    BREAST LESION LOCALIZATION NEEDLE

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

    BREAST LESION LOCALIZATION NEEDLE

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

    BAUER TEMNO COAXIAL NEEDLE

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

    LOCALIZATION WIRE OR MARKER - SURGICAL

    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 →