BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe

    K Number: K222001 · Decision Jun 8, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    13
    Applicant Total
    6
    Review Days
    336

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
    K Number
    K222001
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Zhejiang Curaway Medical Technology Co., Ltd.
    Date Received
    July 7, 2022
    Decision Date
    June 8, 2023
    Product Code
    OAB
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OAB Low Energy Direct Current Thermal Ablation System

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (OAB), ordered by most recent decision date.

    Aliya® EX System; Aliya® EX Generator; Aliya® Needle; Aliya® Electrode; INUMI™ Flex Needle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    NanoKnife Generator (H78720300351US0)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    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)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Electroporation System (N3000)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    INUMI™ Flex Needle

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Zhejiang Curaway Medical Technology Co., Ltd.

    K Number Device Name
    K244018 Disposable Biopsy Needle
    K241793 Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle
    K242322 Bone Marrow Biopsy Needle
    K240758 Radiofrequency Generator System, Cura RF Electrode
    K232505 Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter