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510(k) Data Aggregation

    K Number
    K172120
    Device Name
    Veress Needle
    Manufacturer
    WickiMed (Huizhou) Medical Equipment Manufacturing Co.,Ltd.
    Date Cleared
    2017-09-14

    (63 days)

    Product Code
    FHO, HIF
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The Veress Needle is a sterile and single-use product. It incorporated a spring loaded blunt stylet mechanism similar to the needle. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.
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    K Number
    K121370
    Device Name
    VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE
    Manufacturer
    VECTEC
    Date Cleared
    2013-08-02

    (452 days)

    Product Code
    FHO, FHP, HIF
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VECTEC Disposable Pneumoperitoneum Needle is a single-use, sterile device intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish a pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The VECTEC Disposable Pneumoperitoneum Needle is a disposable, single-use, sterile surgical tool used in laparoscopy for insufflation of the abdominal cavity prior to use of a trocar during abdominal surgery. The device is sterilized using a traditional, validated ethylene oxide procedure per ISO 11135-1: 2007 to a SAL of 10t and with acceptable residual EO levels per ISO 10993-7: 2008.
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    K Number
    K010779
    Device Name
    MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT
    Manufacturer
    GIBBONS SURGICAL CORP.
    Date Cleared
    2001-04-10

    (26 days)

    Product Code
    FHO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K970788
    Device Name
    PNEUMO-MATIC INSUFFLATION NEEDLE
    Manufacturer
    APPLE MEDICAL CORP.
    Date Cleared
    1997-03-27

    (23 days)

    Product Code
    FHO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pneumo-Matic Insufflation Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.
    Device Description
    The Pneumo-Matic Insufflation Needle is a sterile, disposable Veress needle which is available in a 14 gauge, 120mm or 150mm length. The devices are packaged 10 per box. The needle is equipped with a spring-loaded, round-tipped obturator. In addition, there is a "window" and visual indicator in the proximal handle which will visibly confirm penetration of the inner abdominal wall. Integral to the proximal handle is a "slide switch" which permits easy ON-OFF control of the gas flow. The most proximal end contains a male luer lock connector for secure gas line connection.
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    K Number
    K960574
    Device Name
    ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM
    Manufacturer
    SHERWOOD MEDICAL CO.
    Date Cleared
    1996-08-05

    (175 days)

    Product Code
    FHO
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FHO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter is intended to prevent pressure from developing in the chest, averting lung collapse and providing a means for fluid to drain from the chest cavity.
    Device Description
    The Argyle Turkel Neonatal/Pediatric Thoracic Catheter Insertion Tray will include all components commonly required to perform a chest drainage procedure in a single procedure-ready package. This procedure tray will be available in several configurations of tray components. The Neonatal/Pediatric Thoracic Catheter is a sterile, single use indwelling catheter, used to create a patent open passageway between the chest cavity and atmosphere or a Chest Drainage Unit (CDU). The catheter will be available in 8, 10 and 12 fr sizes. The device incorporates a blunt, multi-sideholed, springloaded inner cannula coaxially housed within a conventional sharp-beveled hollow needle. This entire assembly is housed within polyurethane tapered catheter, which is used as a standard small bore percutaneously placed thoracic catheter. The tapered catheter incorporates four distal side-holes to facilitate drainage.
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