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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: GBX FDA class 1

    Catheter, Irrigation

    General, Plastic Surgery

    View full classification →

    The Catheter, Irrigation (product code GBX) is a general-purpose catheter used to irrigate wounds, body cavities, or surgical sites by delivering a flow of fluid to clean or flush the area during surgical procedures. It is classified as FDA Class 1, posing minimal risk, requiring only general controls and no 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.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MOERAE VEIN PREPARATION KIT
    GRAFTGUARD PRESSURE CONTROLLING SYRINGE
    DEUTSCH ANTI-BLOCKAGE WOUND DRAIN
    GRAFTSAVER
    MISONIX IRRIGATION SYSTEM MOEDL BC20P
    DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)
    LYSONIX IRRIGATION SYSTEM
    JACKSON-PRATT HEMADUCT WOUND DRAIN, JACKSON-PRATT GOLD HEMADUCT WOUND DRAIN
    ULTRACELL SUCTION SPONGE
    FLAT CLOSED WOUND DRAIN WITH TROCAR
    SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR
    CLOSED FLUID COLLECTION SYSTEM
    JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING
    HYDROLOGY 5000
    NEO-PNEUMOCATH
    OPTI-DRAIN MULTI-USE DRAINAGE CATHETER
    THE REEL THING (MODIFICATION)
    SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN
    NAVARRE LOCKING PIGTAIL UNIVERSAL DRAINAGE CATHETER
    NAVARRE UNIVERSAL DRAINAGE CATHETER
    INSYTE SIDEHOLDED DRAINAGE CATHETER
    ANGIOCATH SIDEHOLDER DRAINAGE CATHETER
    ACI SILICATH THORACIC CATHETER
    DEKNATEL(TM) PLEUR-EVAC(R) THORACIC CATHETER
    THE REEL THING
    ORION SUCTION CATHETER KIT WITH STERILE WATER
    ORION SUCTION CATHETER KIT WITH STERILE SALINE
    OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP
    STORZ N5941 SERIES MEDICAL GRADE TUBING
    NAVARRE BIOMEDICAL TIP-LOCKING DRAINAGE CATHETERS
    SIL-SLIP FLAT SUCTION DRAIN
    SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE
    NAVARRE BIOMEDICAL UNIVERSAL DRAINAGE CATHETER SET
    ERCP CATHETER, HYDROPHILIC COATED
    URESIL ABSCESS DRIANAGE AND IRRIGATION SET
    FLUID DRAINAGE TRAY
    KENDALL UNIVERSAL EXTENSION SET
    IRRIGATION/SUCTION PROBE
    VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE
    KENDALL WOUND DRAINAGE SYSTEMS-TROCARS
    KENDALL FLAT/ROUND & FLAT SPLITTABLE SILICON DRAIN
    TURKEL ABDOMINAL PARACENTESIS SYSTEM
    ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET
    SIL-MED FLAT SUCTION DRAIN
    HOLLISTER HORIZONTAL DRAIN/TUBE ATTACHMENT DEVICE
    INTRADUCER
    PACER DISPOSABLE YANKAUER SUCTION INSTRUMENT
    THORACIC CATHTER STYLET
    THORACIC CATHETER WITH GUIDE
    I/A HANDPIECE WITH REPLACEABLE TIPS

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

    Popular Product Codes

    Commonly searched
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