BEUDAMED
    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: FCG FDA class 2

    Biopsy Needle

    Gastroenterology, Urology

    View full classification →

    The Biopsy Needle (product code FCG) is a hollow needle used to obtain tissue core samples from the gastrointestinal or genitourinary tract for histological or cytological analysis. It is an FDA Class 2 device (moderate risk), requiring 510(k) premarket clearance. It is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)
    Precision GI
    ClearTip
    EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)
    EndoDrill® Model X
    Disposable Coaxial Biopsy Needle
    Disposable Biopsy Refill Needle
    EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle
    Biopsy Needle
    Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle
    Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N
    Clear-Tip EUS-FNA
    Single Use Aspiration Needle NA-U201H
    Single Use Aspiration Needle NA-U200H
    Beacon EUS Access System
    Sterile Endoscope Biopsy Sampling Needle
    ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle
    Howell Biliary Introducer Needle
    Perineologic Access Needle
    Single Use Aspiration Needle NA-U401SX
    Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle
    Single Use Aspiration Needle NA-U200H
    Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
    Corvocet Coaxial Introducer
    BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
    Echotip Procore HD Ultrasound Biopsy Needle
    HS NOTA
    SHARKCORE FINE NEEDLE BIOPSY SYSTEM
    SONOTIP PRO AND PRO FLEX EBUS-TBNA NEEDLE SYSTEM
    SAFETY BIOPSY NEEDLE SYSTEM
    BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED,
    TISSUE SAMPLING NEEDLE
    BNX FINE NEEDLE ASPIRATION SYSTEM
    RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
    ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
    ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
    MEDI-GLOBE SONOTIP II EBUS-TBNA NEEDLE SYSTEM
    SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025
    ECHOTIP ULTRA ULTRASOUND NEEDLE
    BIOPSY GUIDE KIT FOR 8808 AND BIPLANE, ENDFIRE AND DUAL BIOPSY GUIDES FOR 8818
    TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE
    THYROSAMPLER
    TROKABONE, TROKABONE STERNAL
    SONOTIP II ULTRASOUND NEEDLE SYSTEM
    MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
    K-C HEMOSTATIC BIOPSY SYSTEM
    SONOTIP II ULTRASOUND NEEDLE SYSTEM
    SINGLE USE ASPIRATION NEEDLE NA-201SX-4022
    EASY CORE BIOPSY SYSTEM II
    EASY CORE BIOPSY SYSTEM

    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
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump