BEUDAMED
    Product Code: OCL FDA class 2 21 CFR 878.4400

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

    General, Plastic Surgery

    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.

    View on FDA
    510(k)s
    54
    FEI Numbers
    29
    Registration Numbers
    29
    Unique Applicants
    14
    Years Active
    28

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    Basic Information

    Product Code
    OCL
    Device Class
    FDA class 2
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    CV
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✓
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Surgical device for cutting, coagulation, and/or ablation of tissue, including cardiac tissue

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 54 510(k) clearances via K numbers.

    K Number Device Name
    K252056 Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100)
    K234151 Isolator Synergy EnCapture Ablation System (EMH)
    K221358 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)
    K223508 Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device
    K210477 AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE
    K211311 AtriCure Isolator® Synergy™ Surgical Ablation System
    K200514 Cardioblate Gemini-s Surgical Ablation Device
    K193162 EPi-Sense Guided Coagulation System with VisiTrax
    K192125 Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen
    K191526 Cardioblate CryoFlex Surgical Ablation System
    K190587 Coolrail Linear Pen
    K190623 Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device
    K190151 COBRA Fusion Ablation System
    K182610 Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device
    K183065 Coolrail Linear Pen
    K163408 Isolator Multifunctional Linear Pen
    K142084 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    K130521 ISOLATOR LINEAR PEN
    K123733 CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM
    K120857 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX
    K121878 CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
    K122611 COOLRAIL LINEAR PEN MODEL MCRI
    K121767 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE
    K121451 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE
    K113475 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM
    K110913 ESTECH COBRA SURGICAL SYSTEM WITH THERMASHIELD ACCESSORY
    K110117 ATRICURE BIPOLAR SYSTEM
    K101174 ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2
    K100501 MULTIFUNCTIONAL LINEAR PEN
    K090721 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205
    K090202 NUMERIS GUIDED COAGULATION SYSTEM WITH VISITRAX, MODELS CSK-121, -122, -123 AND -125
    K082203 NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025
    K082279 EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2
    K080292 EPICOR ABLATION SYSTEM
    K080509 CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
    K073605 ATRICURE COOLRAIL LINEAR PEN
    K071819 NCONTACT VISITRAX GUIDED COAGULATION SYSTEM KIT, MODELS CSK-212 AND CSK-515
    K043579 ATRICURE BIPOLAR SYSTEM
    K070288 CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814
    K063012 NCONTACT COAGULATION SYSTEM KIT, MODEL CSK
    K062140 SURGIFROST XL CRYOSURGICAL DEVICE, MODEL 60SFXL; CRYOSURGICAL CONSOLE, MODEL 65CS1
    K061593 ATRICURE ISOLATOR TRANSPOLAR PEN SYSTEM, MODELS ASU2, MAX1, MAX2 AND ASB1
    K060715 MODIFICATION TO: CARDIMA ABLATION SYSTEM
    K053436 SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    K050459 ATRICURE ISOLATOR TRANSPOLAR PEN
    K041890 CRYOCOR MODEL 1250 (BREVA) SERIES SURGICAL PROBES, MODEL 1255-15-12
    K040690 SURGIFROST 10 CM CRYOSURGICAL DEVICE PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE
    K022008 CARDIMA ABLATION SYSTEM
    K021010 MODIFIED CARDIAC CRYOSURGICAL SYSTEM, MODELS 6TCS1 & 6TCSE
    K013392 CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880
    K011988 SURGICAL LIGHTSTIC 180, MODEL 180 L, MODEL 180 C
    K011040 CRYOCARE CARDIAC SURGICAL SYSTEM
    K974320 CRYOGEN CARDIAC CRYOSURGICAL SYSTEM
    K970496 HEARTPORT MAZE SYSTEM: CRYOPROBE SET

    FEI Numbers

    This FDA classification entry is associated with 29 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 29 registration numbers. Click on an entry to view related FDA registrations.