BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM

    K Number: K101592 · Decision Oct 6, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    1
    Review Days
    486

    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
    ERASE HAND- HELD CONTROLLER; ERASE SINGLE USE ELECTRIC CATRIDGE SYSTEM
    K Number
    K101592
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cheng Medical, Corporation
    Date Received
    June 7, 2010
    Decision Date
    October 6, 2011
    Product Code
    GXD
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXD Generator, Lesion, Radiofrequency

    Similar 510(k) Clearances

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

    GX1 Radiofrequency Generator Kit (RFG-X1-120V); GX1 Radiofrequency Generator Kit (RFG-X1-220V); GX1 Radiofrequency Generator Kit (RFG-X1-240V); GX1 System Release Rest of World (GX1-SYS-ROW); GX1 Radiofrequency Generator (51779845-01); GX1 Radiofrequency Generator (51779845-02); GX1 Radiofrequency Generator (51779845-03)

    FDA 510(k)
    FDA Class 2 ·Neurology

    COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R)

    FDA 510(k)
    FDA Class 2 ·Neurology

    Racz Neurostat RF Generator

    FDA 510(k)
    FDA Class 2 ·Neurology

    OneRF Ablation System

    FDA 510(k)
    FDA Class 2 ·Neurology

    APEX 6

    FDA 510(k)
    FDA Class 2 ·Neurology

    Abbott Medical Grounding Pad, model RF-DGP-IS

    FDA 510(k)
    FDA Class 2 ·Neurology
    View all