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

    RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS

    K Number: K011121 · Decision Nov 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    53
    Registration Numbers
    53
    Same Product Code
    55
    Applicant Total
    43
    Review Days
    218

    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
    RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
    K Number
    K011121
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rusch Intl.
    Date Received
    April 12, 2001
    Decision Date
    November 16, 2001
    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 Rusch Intl.

    K Number Device Name
    K033023 INTERMITTENT URETHRAL CATHETERS
    K030559 RUSCH POLYFLEX STENT FOR THE ESOPHAGUS W/INTRODUCER/DELIVERY SYSTEM
    K023666 RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
    K023918 RUSCH CRYSTAL CLEAR TRACHEOSTOMY SETS, CUFFED AND CUFFLESS
    K023964 RUSCH MICROLARYNGEAL TUBE
    K021540 RUSCH EDGAR TUBE
    K021764 RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
    K020714 RUSCH FLONEIL; FLOCATH INTROGEL
    K010798 RUSCH CANTOR TUBE
    K010797 RUSCH MILLER-ABBOTT TUBE
    Search all 43 clearances from Rusch Intl. →