BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS

    K Number: K130736 · Decision Dec 17, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    223
    Registration Numbers
    223
    Same Product Code
    64
    Applicant Total
    4
    Review Days
    274

    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
    BLOM-SINGER ADJUSTABLE BI-FIANGED FISTULA PROSTHESIS
    K Number
    K130736
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Helix Medical, LLC
    Date Received
    March 18, 2013
    Decision Date
    December 17, 2013
    Product Code
    LRC
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LRC Instrument, Ent Manual Surgical

    Similar 510(k) Clearances

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

    BB 8 Sinus Dilation Kit

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    VenSure LightGuide

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    SINUSPRIME Dilation System

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Next Generation Balloon Dilation System

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    VenSure Balloon Device, VenSure Nav Balloon Device

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    Dillard Nasal Balloon Catheter

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat
    View all

    Other Clearances by Helix Medical, LLC

    K Number Device Name
    K131745 BLOM-SINGER SEPTAL PERFORATION PROSTHESIS
    K093258 BLOM-SINGER INDWELLING TEP OCCLUDER
    K082206 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES