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510(k) Data Aggregation

    K Number
    K002582
    Device Name
    PILLING E-FRAZIER BIPOLAR SUCTION TUBE
    Manufacturer
    Date Cleared
    2000-11-03

    (77 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K992476
    Device Name
    PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
    Date Cleared
    2000-09-13

    (415 days)

    Product Code
    Regulation Number
    870.4500
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.
    Device Description
    Pilling Weck Surgical Stabilizer Removable Pads
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    K Number
    K992174
    Device Name
    PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
    Date Cleared
    2000-03-23

    (269 days)

    Product Code
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.
    Device Description
    Aortic Spoon Jaw Clamp
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    K Number
    K990935
    Device Name
    JACKSON ESOPHAGEAL DILATOR
    Date Cleared
    1999-05-17

    (59 days)

    Product Code
    Regulation Number
    876.5365
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.
    Device Description
    Device consists of silicone tip, stainless steel rod and nylon sleeve.
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    K Number
    K990561
    Device Name
    OPTICAL FORCEPS
    Date Cleared
    1999-05-14

    (81 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes
    Device Description
    The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep
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    K Number
    K990547
    Device Name
    PILLING WECK SURGICAL Y STENT FORCEPS
    Manufacturer
    Date Cleared
    1999-04-27

    (64 days)

    Product Code
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures
    Device Description
    The Stent Forceps/(Bronchoscope(Flexible or Rigid) consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.
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    K Number
    K982128
    Device Name
    SHIKANI-FRENCH SPEAKING VALVE
    Date Cleared
    1998-10-23

    (128 days)

    Product Code
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.
    Device Description
    The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.
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    K Number
    K974250
    Device Name
    VERSASTAT MULTIPOLAR SCISSORS AND CABLES
    Manufacturer
    Date Cleared
    1998-02-11

    (90 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    PILLING WECK, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    - to coagulate and transect vascular tissue simultaneously; . - to perform spot coagulation of bleeding vessels; - - to be used in open. surgical procedures; -
    Device Description
    The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface. The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.
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    K Number
    K971334
    Device Name
    PILLING WECK SECONDARY FLEXIBLE SLEEVE WITH TROCAR
    Manufacturer
    Date Cleared
    1997-06-11

    (62 days)

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

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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
    Date Cleared
    1997-03-04

    (70 days)

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

    PILLING WECK GROUP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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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