BEUDAMED
    Product Code: GBO FDA class 1 21 CFR 878.4200

    Catheter, Nephrostomy, General & Plastic Surgery

    General, Plastic Surgery

    The Catheter, Nephrostomy, General and Plastic Surgery (product code GBO) is a catheter used to drain urine directly from the kidney through a percutaneous insertion into the renal pelvis or calyx, typically employed when normal urinary drainage is obstructed. It is classified as FDA Class 1, the lowest risk category, subject to general controls only and not requiring premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.

    View on FDA
    510(k)s
    11
    FEI Numbers
    53
    Registration Numbers
    53
    Unique Applicants
    6
    Years Active
    26

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    Basic Information

    Product Code
    GBO
    Device Class
    FDA class 1
    Regulation Number
    878.4200
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 11 510(k) clearances via K numbers.

    K Number Device Name
    K041995 MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY
    K021632 GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C
    K912109 URESIL GENERAL PURPOSE DRAINAGE CATHETER
    K854911 PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)
    K854909 PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS
    K854907 PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)
    K854906 PERCUTANEOUS NEPHROSTOMY SETS (OTTO)
    K854905 PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE)
    K820867 PERCUTANEOUS NEPHROSTOMY SET
    K781664 SILASTIC NEPHROSTOMY SYSTEM
    K781526 SILASTIC U-TUBE KIT

    FEI Numbers

    This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.