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: OCL FDA class 2

    Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue

    General, Plastic Surgery

    View full classification →

    The Surgical Device for Cutting, Coagulation, and/or Ablation of Tissue Including Cardiac Tissue (product code OCL) is a general and plastic surgery instrument capable of cutting, coagulating, and/or ablating soft tissue including cardiac tissue, used across a range of surgical applications. The device encompasses energy-based surgical tools applied during open or minimally invasive procedures. This device is FDA Class 2 under regulation 878.4400 in the General, Plastic Surgery specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Isolator Synergy EnCapture Ablation System (EMH)
    Isolator® Linear Pen (MLP1); Isolator® Transpolar™ Pen (MAX1, MAX5), Coolrail® Linear Pen (MCR1); Isolator® Synergy Surgical Ablation System (EMR2, EML2); Isolator® Synergy™ EnCompass Clamp (OLH, OSH) and Guide System; Isolator® Synergy Access Clamp (EMT1)
    Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
    AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
    AtriCure Isolator® Synergy™ Surgical Ablation System
    Cardioblate Gemini-s Surgical Ablation Device
    EPi-Sense Guided Coagulation System with VisiTrax
    Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
    Cardioblate CryoFlex Surgical Ablation System
    Coolrail Linear Pen
    Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
    COBRA Fusion Ablation System
    Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
    Coolrail Linear Pen
    Isolator Multifunctional Linear Pen
    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    ISOLATOR LINEAR PEN
    CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
    EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
    COOLRAIL LINEAR PEN MODEL MCRI
    CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
    CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
    ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    ATRICURE BIPOLAR SYSTEM
    ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
    MULTIFUNCTIONAL LINEAR PEN
    CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
    NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
    NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025
    EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
    EPICOR ABLATION SYSTEM
    CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
    ATRICURE COOLRAIL LINEAR PEN
    NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
    ATRICURE BIPOLAR SYSTEM
    CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
    NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
    SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
    ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
    MODIFICATION TO: CARDIMA ABLATION SYSTEM
    SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    ATRICURE ISOLATOR TRANSPOLAR PEN
    CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
    SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    CARDIMA ABLATION SYSTEM
    MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
    CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
    SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C

    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