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510(k) Data Aggregation

    K Number
    K030311
    Device Name
    HEM-O-LOK XL CLIP
    Manufacturer
    WECK
    Date Cleared
    2003-02-26

    (27 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WECK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    The Weck Hem-O-Lok™ ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-o-Lok™ causes hemostasis through vessel ligation. The modified XL size clip is a larger version of the existing Hem-o-lok clip.
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    K Number
    K021808
    Device Name
    WECK HEM-O-LOK AUTOMATIC LIGATING CLIP APPLIER
    Manufacturer
    WECK
    Date Cleared
    2002-08-14

    (72 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WECK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.
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    K Number
    K011660
    Device Name
    WECK CARDIAC PACING WIRES
    Manufacturer
    WECK CLOSURE SYSTEMS
    Date Cleared
    2001-08-21

    (84 days)

    Product Code
    LDF
    Regulation Number
    870.3680
    Why did this record match?
    Applicant Name (Manufacturer) :

    WECK CLOSURE SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.
    Device Description
    Weck cardiac pacing wires consist of a small curved stainless steel needle attached to fluoropolymer coated stainless steel braided wire which is attached on the opposite end to a Keith or Milner breakaway needle (see picture below). The wire is bare at the distal end to allow conduction of pacing signals to the heart. This is a standard temporary epicardial pacing wire design. There are three design variations included in this submission that are offered as a convenience to the user: 1. Color coding White and orange color coding of the insulation allows the user to differentiate between atrial and ventricular wires after chest closure. 2. Heart needle Three heart needle sizes are intended to allow for variations in physiology between patients. Another variation has no curved heart needle for surgeons who prefer to suture the wire to the epicardium rather than implanting it. 3. Retention feature A "wing" version wire is formed by peeling back the insulation in three places, 120° apart, for a distance of 1/2" near the curved heart needle. The "wing" is intended as a convenience feature to provide a suture-free method of securing the electrode to the heart.
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    K Number
    K003337
    Device Name
    HEM-O-LOK SMX, MODEL 544220; HEM-O-LOK ML, MODEL 544230; HEM-O-LOK MLX, MODEL 544240
    Manufacturer
    WECK CLOSURE SYSTEMS
    Date Cleared
    2000-12-21

    (57 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WECK CLOSURE SYSTEMS

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

    (415 days)

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

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    2000-03-23

    (269 days)

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

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    K993157
    Device Name
    HEM-O-LOK SMX POLYMER CLIPS, MODEL 544220, HEM-0-LOK MLX POLYMER CLIPS, MODEL 544240
    Manufacturer
    WECK CLOSURE SYSTEMS
    Date Cleared
    1999-12-17

    (87 days)

    Product Code
    FZP
    Regulation Number
    878.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WECK CLOSURE SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
    Device Description
    Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal. The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.
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    K Number
    K990935
    Device Name
    JACKSON ESOPHAGEAL DILATOR
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1999-05-17

    (59 days)

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

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    Manufacturer
    PILLING WECK SURGICAL
    Date Cleared
    1999-05-14

    (81 days)

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

    PILLING WECK SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
    PILLING WECK, INC.
    Date Cleared
    1999-04-27

    (64 days)

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

    PILLING WECK, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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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