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

    CIRCLE NEPHROSTOMY CATHETER SET

    K Number: K961933 · Decision Jul 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    104
    Review Days
    62

    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
    CIRCLE NEPHROSTOMY CATHETER SET
    K Number
    K961933
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Urological, Inc.
    Date Received
    May 17, 1996
    Decision Date
    July 18, 1996
    Product Code
    LJE
    Advisory Committee
    Unknown
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LJE Catheter, Nephrostomy

    Similar 510(k) Clearances

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

    Disposable Percutaneous Nephrostomy Dilatation Kit

    FDA 510(k)
    FDA Unclassified ·Unknown

    Introducer Needle

    FDA 510(k)
    FDA Unclassified ·Unknown

    Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets

    FDA 510(k)
    FDA Unclassified ·Unknown

    In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath

    FDA 510(k)
    FDA Unclassified ·Unknown

    Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc

    FDA 510(k)
    FDA Unclassified ·Unknown

    Lawson Retrograde Nephrostomy Wire Puncture Set

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Cook Urological, Inc.

    K Number Device Name
    K102141 COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)
    K091767 3 WAY SILICONE FOLEY BALLOON CATHETER
    K082939 COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400
    K082066 TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER
    K082536 COOK WIRE GUIDES
    K082319 INJEKT FILIFORM INJECTION NEEDLE
    K080525 COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W
    K073496 OPTILITE HOLMIUM LASER FIBERS
    K072521 COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH
    K061371 SYDNEY IVF SPERM CRYOPRESERVATION BUFFER
    Search all 104 clearances from Cook Urological, Inc. →