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

    PAINBLOCKER WA5000

    K Number: K854334 · Decision Apr 30, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    22
    Applicant Total
    27
    Review Days
    184

    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
    PAINBLOCKER WA5000
    K Number
    K854334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4250
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Applicant
    Wallach Surgical Devices, Inc.
    Date Received
    October 28, 1985
    Decision Date
    April 30, 1986
    Product Code
    GXH
    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
    GXH Device, Surgical, Cryogenic

    Similar 510(k) Clearances

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

    cryoICE cryoXT cryoablation probe (cryoXT)

    FDA 510(k)
    FDA Class 2 ·Neurology

    iovera° System

    FDA 510(k)
    FDA Class 2 ·Neurology

    AtriCure cryoICE BOX (ACM)

    FDA 510(k)
    FDA Class 2 ·Neurology

    cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP); cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP-L); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX); cryoICE cryoSPHERE MAX Cryoablation Probe (CRYOSMAX-L)

    FDA 510(k)
    FDA Class 2 ·Neurology

    iovera System

    FDA 510(k)
    FDA Class 2 ·Neurology

    Iovera System

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

    Other Clearances by Wallach Surgical Devices, Inc.

    K Number Device Name
    K021224 ENDOCERVICAL BLOCK NEEDLE
    K020711 WALLACH LOOP ELECTRODE
    K000768 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    K992736 WALLACH'S ULTIMATE REUSABLE, PLASTIC VAGINAL SPECULUM
    K991669 PMS 750 FINGERSWITCH
    K983840 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR (PROPOSED)
    K984306 `THE INSEMINATOR' (PROPOSED)
    K983208 WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
    K963653 WALLACH QUANTUM 2000 ELECTROSURGICAL SYSTEM
    K963348 WALLACH INTEGRATION UNIT
    Search all 27 clearances from Wallach Surgical Devices, Inc. →