BEUDAMED
    Product Code: OAB FDA class 2 21 CFR 878.4400

    Low Energy Direct Current Thermal Ablation System

    General, Plastic Surgery

    The Low Energy Direct Current Thermal Ablation System (product code OAB) is a surgical device used for the ablation of soft tissue using low-energy direct current thermal energy. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 878.4400 within the General and Plastic Surgery specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.

    View on FDA
    510(k)s
    14
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    8
    Years Active
    19

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    Basic Information

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

    Device Characteristics

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

    Definition

    Ablation of soft tissue

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 14 510(k) clearances via K numbers.

    K Number Device Name
    K253826 Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle
    K253198 NanoKnife Generator (H78720300351US0)
    K242687 NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010)
    K240376 Electroporation System (N3000)
    K233884 INUMI™ Flex Needle
    K240297 Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
    K222001 Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
    K212871 Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode
    K183385 NanoKnife System
    K150089 NanoKnife System
    K102329 NANOKNIFE SYSTEM
    K080202 ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT
    K080376 ONCOBIONIC SYSTEM
    K060054 ONCOBIONIC SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.