BEUDAMED
    FDA Registration Active 🇺🇸 United States

    72290037 Werewolf FLOW 50 Coblation Wand (E-beam)

    Reg #: 1643264 · FEI: 1643264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1643264
    FEI Number
    1643264
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    ENDOSCOPY, 76 S. MERIDIAN AVE.
    City
    OKLAHOMA CITY
    State
    OK
    ZIP
    73107
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162074

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    72290037 Werewolf FLOW 50 Coblation Wand (E-beam) 72290068 Werewolf Power Cord/Manual - Japan 72290064 Werewolf Power Cord/Manual - Korea 72290062 Werewolf Power Cord/Manual - Scandinavia 72290060 Werewolf Power Cord/Manual - EU Spanish 72290057 Werewolf Power Cord/Manual - US English 72290065 Werewolf Power Cord/Manual - Switzerlalnd 72290067 Werewolf Power Cord/Manual -Australia Werewolf Cobation System (RF20000) with FLOW IQ Technology 72290008 Wireless Foot Contol 72290063 Werewolf Power Cord/Manual - Russia 72290059 Werewolf Power Cord/Manual - W. Europe 72290061 Werewolf Power Cord/Manual - EU English 72290058 Werewolf Power Cord/Manual - N. America 72290066 Werewolf Power Cord/Manual - China 72290105 Werewolf RF20000 Controller 72290007 Wired Foot Control Super TurboVac 90 IFS Ambient Super TurboVac 90 CoVator 20 Ambient MegaVac 90 Super TurboVac 90 StarVac 90 Sidewinder Blade TOPAZ EZ MicroDebrider IFS Ambient CoVac 70 IFS KVac Ambient CoVac 50 IFS TOPAZ XL IFS Ambient Kvac IFS Ambient HipVac 50 IFS

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device