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

    VISICLEAR SMOKE EVACUATION SYSTEM

    K Number: K131402 · Decision Mar 3, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    73
    Registration Numbers
    73
    Same Product Code
    74
    Applicant Total
    22
    Review Days
    292

    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
    VISICLEAR SMOKE EVACUATION SYSTEM
    K Number
    K131402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5070
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Buffalo Filter Co., Inc.
    Date Received
    May 15, 2013
    Decision Date
    March 3, 2014
    Product Code
    FYD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FYD Apparatus, Exhaust, Surgical

    Similar 510(k) Clearances

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

    PlumeSafe X5 Smoke Management System

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

    8Q10 Surclear Smoke Plume Evacuation System

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

    Medline Smoke Evacuation Shroud

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

    NEBULAE SRS Laparoscopic Surgical Smoke Removal System

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

    Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor

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

    EvaQMax Smoke Evacuation System

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

    Other Clearances by Buffalo Filter Co., Inc.

    K Number Device Name
    K000904 PENADAPT 10
    K983298 BUFFALO FILTER VIROSAFE ERBIUM:YAG FILTER - #VSEYAG1-4 BUFFALO FILTER VIROSAFE ERBIUM:YAG PREFILTER - #BFEYAG04PF
    K983364 BUFFALO FILTER VIROSAFE 18 FILTER-CATALOG #VSO1801
    K983333 BUFFALO FILTER VIROSAFE HRF- #VSHRFO1
    K943226 BUFFALO FILTER REPLACEMENT FILTER #BSPF030
    K943227 BUFFALO FILTER REPLACEMENT FILTER #BSUCF03
    K930067 BUFFALO FILTER SURGICAL MASK
    K930058 BUFFALO FILTER REPLACEMENT FILTER #BPTU100
    K930062 BUFFALO FILTER REPLACEMENT FILTER #BST300UL
    K930063 BUFFALO FILTER REPLACEMENT FILTER #BCULPA
    Search all 22 clearances from Buffalo Filter Co., Inc. →