LogoFDA 510(k) Search
Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K162932
    Device Name
    Ranfac Fat Aspiration Cannula
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2017-01-19

    (91 days)

    Product Code
    MUU
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranfac Fat Aspiration Cannula is intended for use in aesthetic body contouring. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.
    Device Description
    The Ranfac Fat Aspiration Cannula consist of silicone coated stainless steel tubing that is closed on the distal end and has fenestrations in the side wall to allow fat to be aspirated into the tubing. There is a Luer Lock compatible handle made of ABS plastic, molded to the cannula.
    Ask a Question
    K Number
    K140991
    Device Name
    RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2014-09-11

    (147 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranfac Aspiration Needle with Adjustable Guide is intended for use for aspiration of bone marrow or autologous blood using a standard piston syringe.
    Device Description
    The Ranfac Aspiration Needle with Adjustable Guide consists of a stainless steel cannula, and two stainless steel stylets. All of the aforementioned have handles molded of ABS plastic. The cannula has an Adjustable Guide, also molded of ABS plastic that can be used as a depth guide.
    Ask a Question
    K Number
    K131157
    Device Name
    RANFAC BONE MARROW ASPIRATION NEEDLE
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2013-10-22

    (181 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranfac Bone Marrow Aspiration Needle is intended for use in aspirating bone marrow.
    Device Description
    The Ranfac Bone Marrow Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
    Ask a Question
    K Number
    K031344
    Device Name
    RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2003-05-23

    (24 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Goldenberg SNARECOIL™ Soft Tissue Biopsy (GSS) Needle is intended for obtaining a percutaneous soft tissue biopsy.
    Device Description
    The subject device is a sterile disposable product featuring a stationary stylet that punctures, a spring activated cannula that cuts and a SNARECOIL that captures tissue. The device functions by pulling back the pull ring until the trigger cocks and pressing the trigger until the device fires. The biopsy is captured by the snare located inside the outer needle cannula.
    Ask a Question
    K Number
    K012224
    Device Name
    SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
    Manufacturer
    RANFAC CORP.
    Date Cleared
    2001-08-22

    (67 days)

    Product Code
    KNW, FCG
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ranfac Single Action Biopsy Needle is intended for obtaining a percutaneous soft tissue biopsy.
    Device Description
    Ranfac Single Action Biopsy Needle
    Ask a Question
    K Number
    K961922
    Device Name
    RDP-2
    Manufacturer
    RANFAC CORP.
    Date Cleared
    1996-08-09

    (84 days)

    Product Code
    HET
    Regulation Number
    884.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    RANFAC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1