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510(k) Data Aggregation

    K Number
    K971334
    Device Name
    PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    Manufacturer
    PILLING WECK GROUP
    Date Cleared
    1997-06-11

    (62 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement. The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve. Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.
    Device Description
    The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch. The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style. The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
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    K Number
    K965176
    Device Name
    PILLING WECK 2 PIECE TAKE-APART INSTRUMENTS
    Manufacturer
    PILLING WECK GROUP
    Date Cleared
    1997-03-04

    (70 days)

    Product Code
    OCZ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.
    Device Description
    The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.
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    K Number
    K964450
    Device Name
    SECONDARY TROCAR AND SLEEVE WITH INSUFFLATION PORT
    Manufacturer
    PILLING WECK GROUP
    Date Cleared
    1997-01-10

    (65 days)

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

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Secondary Trocar and Sleeve with Insufflation Port are manual surgical instruments used to support a cut down(lap approach). The secondary trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
    Device Description
    The device consists of a Secondary Trocar and Sleeve with Insufflation Port with mounted cap. The cap consists of a universal adapter seal with reducer, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Secondary Trocar is constructed with a stainless steel tip and is available in pyramidal style and has a polymer handle and upper shaft. The Sleeve, proportionally sized, is made of polymer, threaded and contains an insufflation port . There is a mounted cap assembly, which has a universal adapter seal with guiding port and reducer.
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    K Number
    K964123
    Device Name
    REUSABLE TROCAR WITH SLEEVE (COMMON)
    Manufacturer
    PILLING WECK GROUP
    Date Cleared
    1996-12-12

    (58 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reusable Trocars and Cannula with Insufflation Ports are manual surgical instruments used to support a cut down(lap approach). The trocar is used in Endoscopic Surgery(Gynecologic, general and other laparoscopic procedures and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
    Device Description
    The device consists of Reusable Trocars and Cannula with Insufflation Port with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch. The Reusable Trocars are constructed with a stainless steel shaft and are available in pyramidal style. The Reusable Shielded Trocar is available with a conical or pyramidal tip. The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
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    K Number
    K963815
    Device Name
    REUSABLE TROCAR WITH SLEEVE (COMMON)
    Manufacturer
    PILLING WECK GROUP
    Date Cleared
    1996-11-05

    (43 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reusable Trocar and Sleeve are manual surgical instruments used to support a cut down(lap approach) on secondary puncture placement. The trocar is used in Endoscopic Surgery(Abdominal and Thoracic) for incision and peritoneal access for positioning of the hollow sleeve. Once the trocar is removed, the port of entry provided by the sleeve, through the cap, is used with manual surgical instruments, endoscopic instruments, laproscopes, and probes. There is an seal on the cap, which closes the port of entry.
    Device Description
    The device consists of Reusable Trocars and Sleeves, with available Single Use Disposable Caps. The Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum. The Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch. The Reusable Trocar, sizes 3mm -11mm. , is constructed with a stainless steel shaft and is available in pyramidal style. The Sleeve, proportionally sized, is made of polymer and accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.
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