LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K162388
    Device Name
    CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas(PICS-AF)
    Manufacturer
    CURASEAL, INC.
    Date Cleared
    2017-02-03

    (162 days)

    Product Code
    FTM
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CURASEAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AFTM) is for implantation to reinforce soft tissue for the repair of anal and rectal fistulas.
    Device Description
    The CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas (PICS-AF") is a medical device consisting of a Sealing Disk, Sheath, Dilator, Collagen Matrices and resorbable sutures. The PICS-AF Closure System is designed as a sphincter-sparing device that inhibits the movement of enteric matter into the anorectal fistula tract and to provide a scaffold for tissue ingrowth to occur to close the anorectal fistula.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1