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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: GEH FDA class 2

    Unit, Cryosurgical, Accessories

    General, Plastic Surgery

    View full classification →

    Cryosurgical Unit Accessories (product code GEH) are components and accessories used in conjunction with cryosurgical units, which apply extreme cold to destroy abnormal or diseased tissue in general and plastic surgery settings. This device is classified as an FDA Class 2 device, representing moderate risk, and requires premarket notification (510(k)) clearance before marketing. Regulated under 21 CFR 878.4350 within the General, Plastic Surgery specialty (SU), it is eligible for third-party review as part of the 510(k) process.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ERBECRYO 2 Cryosurgical Unit and Accessories
    ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit; Erbe Flexible Cryoprobe
    Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
    XSense Cryoablation System with CryoProbes
    CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01); CoolCryo - Control console for cardiac cryoablation with liquid nitrogen reservoir (CC01-21)
    Dr. Yglo Skin Tag Remover
    Focused Cryotherapy System
    TargetCool™ (RM-DT02W)
    CryoFreeze Wart and Skin Tag Remover
    TargetCool-e
    Verruca-Freeze H Plus
    Skin Clinic Freeze Point for Warts and Skin Tags
    Skin Clinic Nitro Clear Wart Remover
    CryoFreeze Wart and Skin Tag Remover
    Co-Ablation System with Sterile Co-Ablation Probe
    Advanced Cryo Wart Remover
    Verruca-Freeze H
    Compound W Skin Tag Remover
    Freeze Point & Private Label Versions
    IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)
    Celsio Flexible Cryocatheter System
    C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System)
    XSense Cryoablation System with Cryoprobes
    Histofreezer V
    ICEfx Cryoablation System (FPRCH8000-02)
    Verruca-Freeze® H
    CryoThin™ Surgical System and Accessories
    IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)
    Visual-ICE Cryoablation System
    TargetCool™
    Hydrozid Precise
    Claritag Advanced
    ISOLIS Cryoprobe
    truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
    truFreeze Console, PN CC301; Aire PV Passive Venting Catheter, PN CO840703; 16 Fr CDT 5 Pack, PN 2000181; 20Fr CDT 5 Pack, PN ACCCC3CDT05; Active Venting Spray Kit, 20 Fr CDT, PN 2000177; Active Venting Spray Kit 16 Fr CDT, PN 20000516; Rapid AV Catheter 5 Pack, PN 2000184
    TargetCool
    Freeze’n Clear Skin Clinic Warts & Tags
    TargetCool
    Urethral Warming Catheter Kit
    C2 CryoBalloon Ablation System
    CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
    Hydrozid
    CryoVIVE
    Dr. Yglo Wart Remover
    Forwarts
    Vortex Radial Spray Catheter
    C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
    IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle
    Dermal Cooling System
    CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice

    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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