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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: FAD FDA class 2

    Stent, Ureteral

    Gastroenterology, Urology

    View full classification →

    The Ureteral Stent (product code FAD) is an implantable tubular device placed within the ureter to maintain patency and facilitate urine drainage from the kidney to the bladder, commonly used after urological procedures or to relieve obstructions. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.4620 in the Gastroenterology and Urology specialty. This device is designated as an implant and is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Ureteral Stents (AF-D series)
    Disposable ureteral stent
    Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set
    RELIEF™ Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF™ Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
    APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg
    ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits
    RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm
    NovoFlow Reinforced Ureteral Stent
    JFil Ureteral Stents, JFil Ureteral Stents ECO KIT
    Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System
    Vortek Single Loop Ureteral Stent
    Ureteral Stent Systems, Biliary Drainage Catheters
    Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip
    Dornier Ureteral Stent
    Tria Soft Ureteral Stent
    Tria Firm Ureteral Stent
    Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set
    Greene Renal Transplant Stent Set
    ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent
    Seidmon Antegrade AQ Stent Set
    Malecot Nephrostomy Catheter/Stent Set
    Sof-Flex Ureteral Stent Set
    Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
    Black Silicone Filiform Double Pigtail Stent Set
    RocaJJ Soft Stents
    VORTEK URETERAL DOUBLE LOOP STENT
    VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
    BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
    pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
    Salle Intraoperative Pyeloplasty Stent Set
    Tria Firm Ureteral Stent
    Kwart Retro-Inject Ureteral Stent
    C-Flex Ureteral Stent Set
    Universa Firm Ureteral Stents and Stent Sets
    pAguaMedicina PERSISTENT Structural Hydrogel Ureteral Stent
    ConvertX Nephroureteral Stent System
    Ultrathane Endoureterotomy Stent Set
    Universa Soft Ureteral Stents and Stent Sets
    EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM
    PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX
    FOSSA URETERAL OPEN STENTS
    RESONANCE METALLIC URETERAL STENT
    PEDIATRIC URETERAL STENT
    BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET
    BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
    MODIFICATION TO URETERAL STENT
    MODIFICATION TO FOSSA URETERAL STONE SWEEPER
    MODIFICATION TO CONTOUR POLARIS URETERAL STENT
    BARD ER URETERAL STENT WITH SUTURE
    PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X

    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.

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