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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: KNW FDA class 2

    Instrument, Biopsy

    Gastroenterology, Urology

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    A Biopsy Instrument is a device used in gastroenterology, urology, and surgery to obtain tissue specimens from organs and lesions for histopathological examination, including needle, forceps, and punch biopsy configurations used endoscopically or percutaneously. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KNW and it is regulated under 21 CFR 876.1075 in the Gastroenterology and Urology specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Promisemed VeriEcto Automatic Biopsy Needles
    Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery Char
    ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863212130 / ZeniCore Automatic Biopsy Device 12ga x 13cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214100 / ZeniCore Automatic Biopsy Device 14ga x 10cm with Coaxial Introducer Kit); ZeniCore™ Automatic Biopsy Instrument (863214130 / ZeniCore Automatic Biopsy Device 14ga x 13cm with Coaxial
    EnCor EnCompass™ Breast Biopsy and Tissue Removal System
    Resitu Slider 09 (RESL09)
    Forcyte Autograft Harvest Kit
    Disposable Biopsy Needle
    Disposable Biopsy Needle
    Marquee™ Disposable Core Biopsy Instrument and Instrument Kit
    ExpressCore Biopsy Device
    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
    Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle)
    Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
    Bone Marrow Biopsy Needle
    Triopsy Actuator (TMSDGB); Triopsy Biopsy Needle (BN-1825-36-01); Triopsy Biopsy Needle (BN-1825-55-01)
    Mammotome AutoCore™ Single Insertion Core Biopsy System
    TRAP EASY
    ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)
    Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM
    M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle
    SUREcore Prime Biopsy Instrument
    EnCor Enspire™Breast Biopsy System (E4115, E4230); EnCor™ Breast Biopsy Driver (DRENCOR); EnCor™ MRI Breast Biopsy Driver (DRENCORMR); EnCor™ Breast Biopsy Driver Probes (ECP017G, ECP017GV, ECP0110G, ECP0110GV, ECP0112G, ECP0112GV); EnCor™ MRI Breast Biopsy Probes (ECPMR017G, ECPMR0110G, ECPMR0110GBT)
    OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver
    Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument
    M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle
    Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA)
    Semi-automatic Biopsy-Needle (BIM 18/20); Semi-automatic Biopsy-Needle (BIM 18.15); Semi-automatic Biopsy-Needle (BIM 18/10);Semi-automatic Biopsy-Needle (BIM 16/20);Semi-automatic Biopsy-Needle (BIM 16/15);Semi-automatic Biopsy-Needle (BIM 16/10);Semi-automatic Biopsy-Needle (BIM 14/20);Semi-automatic Biopsy-Needle (BIM 14/15);Semi-automatic Biopsy-Needle (BIM 14/10)
    SUREcore Plus Biopsy Instrument
    NeoNavia Biopsy System
    Disposable Semi Automatic Biopsy Instrument
    NovaCore Semi-Automatic Biopsy Instrument
    Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle
    Promisemed Fine Biopsy Needle
    BD Trek Powered Bone Biopsy System
    TeesuVac Breast Biopsy Device Mark 1
    Arthrex Vortex Threaded Bone Marrow Recovery Needle
    Disposable Automatic Core Biopsy Instrument
    Uramix CuraWay Biopsy Needle
    Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles
    EleVation Breast Biopsy System
    EnCor Breast Biopsy Probe with Rinse Tube
    Avitus(r) Bone Harvester
    VMCore Biopsy Needle
    Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
    Ran-Flex-B Bone Marrow Aspiration Needle
    Temno Elite Biopsy System
    Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System
    Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices
    MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System
    Medone Ultra, Medextra

    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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