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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: FZP FDA class 2

    Clip, Implantable

    General, Plastic Surgery

    View full classification →

    The Clip, Implantable (product code FZP) is a small implantable device used in general and plastic surgery to occlude, secure, or approximate tissue or vessels inside the body, remaining in place after the procedure. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification to demonstrate substantial equivalence before marketing. The device is regulated under 21 CFR 878.4300 within the General, Plastic Surgery specialty (SU). This device carries an implant designation, as it is intended to be placed within the human body.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips
    GEM ZIPCLIP
    SOLID CLIP™ Single Use Clip Applier
    Hem-o-lok® Ligating Clips
    angiOCCLUDE Ligating Clips
    LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320)
    Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)
    DuraFuse Clip and Applier System
    angioLOCK Polymer Ligating Clip
    InnoClip Disposable Clip Applier, InnoClip Clip Applier
    Mirus Ligating Clip, Mirus Ligating Clip Applier
    Aesculap PAS-Port Proximal Anastomosis System
    Dannik Titanium Ligation Clip
    Amsel Endo Occluder
    LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier
    AnastoClip GC Closure System
    AtriClip FLEX-V
    AtriClip LAA Exclusion System with Preloaded PRO·V Clip
    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (PRO2)
    Amsel Occluder Device
    AtriClip PRO, PRO2, and PRO V LAA Exclusion System devices with preloaded Gillinov-Cosgrove Clip
    Weck Auto Endo10 Automatic Endoscopic Clip Applier
    Vas-Q-Clip
    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
    Vesocclude Polymer Ligating Clip
    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove PRO V Clip
    CLIP PLUS Disposable Clip Applier,ML;CLIP PLUS Disposable Clip Applier,L
    SureClip
    Premium Surgiclip¿; Endo Clip¿; AcuClip¿
    Ligaclip 10mm M/L Endoscopic Rotating Multiple Clip Applier
    Weck Auto Endo5 Hem-o-lok Ligating Clip Applier
    AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip
    Lapro-Clip Auto Suture Reusable Long Clip Applier
    AMSEL OCCLUDER DEVICE
    Weck Hem-o-lok Auto Endo5 Ligating Clip Applier
    Premium Surgiclip III
    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
    HEM-O-LOK LIGATING CLIP
    HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPS
    ATRICLIP GILLINOV-COSGROVE LAA CLIP
    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP
    ENDO CLIP III 5MM CLIP APPLIER
    ACKERMANN EUROPCLIP
    LIGAMAX 5
    COLONRING
    ENDOSCOPIC CLIP SYSTEM
    CARDICA C-PORT XA PLUS DISTAL ANASTOMOSIS SYSTEM, MODEL FG-000100
    ATRICLIP LAA EXCLUSION SYSTEM WITH PRELOADED GILLINOV-COSGROVE CLIP, GILLINOV-COSGROVE SECTION GUIDE MODEL VARIOUS LAA0
    ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP
    AUTO SUTURE ENDO CLIP III5MM CLIP ADAPTER

    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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