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

    CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET

    K Number: K980123 · Decision Mar 9, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    1391
    Applicant Total
    12
    Review Days
    54

    Basic Information

    Device Name
    CARTER-THOMASON NEEDLE-POINT SUTURE PASSER INSTRUMENT SET
    K Number
    K980123
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    LOUISVILLE LABORATORIES, INC.
    Date Received
    January 14, 1998
    Decision Date
    March 9, 1998
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    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
    GCJ Laparoscope, General & Plastic Surgery

    Similar 510(k) Clearances

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

    Disposable Trocars

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    8 mm Assist Cannula; 12 mm Assist Cannula

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Boehringer Laboratories Liver Retractor

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Medical Monitor (32HS710S)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Arthrex Synergy Vision Endoscopic Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    LAGIS Suction Irrigation System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by LOUISVILLE LABORATORIES, INC.

    K Number Device Name
    K971796 LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS
    K971791 VAGINAL SUTURING KIT FOR LAPAROTOMY BLADDER NECK SUSPENSION
    K971802 VAGINAL SUTURING KIT FOR BLADDER NECK SUSPENSION
    K971797 LAPAROSCOPIC BLADDER NECK SUSPENSION KIT
    K971801 LAPAROTOMY BLADDER NECK SUSPENSION KIT
    K963076 LAPAROSCOPIC BONE ANCHORED URETHROPEXY INSTRUMENT TRAY
    K960882 CONTROL SYRINGE
    K955535 LOUISVILLE LABS OXYGEN HEAD TENT
    K946282 UNIVERSAL URETHRAL CATHETER
    K932979 EXTERNAL STABILITY PAD
    Search all 12 clearances from LOUISVILLE LABORATORIES, INC. →