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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: LJE FDA unclassified

    Catheter, Nephrostomy

    Unknown

    View full classification →

    A nephrostomy catheter is a tube inserted percutaneously through the skin and into the renal pelvis to provide drainage of the kidney when normal urine flow through the ureter is obstructed due to stones, strictures, tumors, or post-surgical complications. This device is currently unclassified by the FDA, meaning a formal regulatory risk classification has not yet been established. It carries product code LJE and no regulation number or medical specialty has been assigned. No special flags apply to this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Disposable Percutaneous Nephrostomy Dilatation Kit
    Introducer Needle
    Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets
    In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
    Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc
    Lawson Retrograde Nephrostomy Wire Puncture Set
    Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set
    Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle
    Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set
    Ultraxx Nephrostomy Balloon Catheter Set
    Ultraxx Nephrostomy Balloon Catheter
    Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
    Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
    RetroPerc Flexible Ureteroscopy-Guided Retrograde Nephrostomy Wire Puncture Set
    GYRUS ACMI NEPHRO - EZDILATE NEPHROSTOMY BALLOON DILATION CATHETER
    NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER
    X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
    X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
    X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
    COOK NEPHROSTOMY DILATION BALLOON CATHETER SET
    RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
    ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
    URESIL PERCUTANEOUS DRAINAGE CATHETERS WITH HYDROPHILIC COATING
    MANAN NEPHROSTOMY DRAINAGE CATHETER
    MANAN GENERAL UTILITY DRAINAGE CATHETER
    URESIL NEPHRO-URETERAL STENT
    CIRCLE NEPHROSTOMY CATHETER SET
    MANAN UNIVERSAL SUMP DRAINAGE CATHETER
    MANAN GENERAL UTILITY DRAINAGE CATHETER
    MANAN NEPHROSTOMY DRAINAGE CATHETER
    NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER
    DILATATION CATHETER, BALLOON
    NEPHRO-URETERAL STENT
    PERCUTANEOUS GRAINAGE CATHETER
    MALECOT-NEPHROSTOMY TAMPONADE CATHETER
    URESIL SUMP DRAINAGE CATHETER
    URESIL NEPHROSTOMY CATHETER
    BALLOON (NEPHROSTOMY TRACT) DILATION CATHETER SET
    NEPHROSTOMY SET
    MENTOR PERCUTANEOUS MALECOT NEPHROSTOMY SET
    MENTOR PERCUTANEOUS COIL NEPHROSTOMY SET
    NEPHROSTOMY GUIDEWIRE SHEATH
    NEPHROSTOMY DRAINAGE CATHETER & STIFFENER
    PERCUTANEOUS NEPHROSTOMY TROCAR SYS
    CURITY SILICONE NEPHROSTOMY CATHETER
    E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
    CURITY SUPRAPUBIC DRAINAGE SYSTEM
    E-Z-EM PERCUTANEOUS NEPHROSTOMY SETS
    PERCUTANEOUS RETROGRADE NEPHROSTOMY
    NEPHROSTOMY/BILIARY DRAINAGE BAG

    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

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