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510(k) Data Aggregation

    K Number
    K141952
    Device Name
    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP, ENDOPATH ECHELON VASCULAR WHITE RELOADS FOR ADVANCED
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2014-11-24

    (129 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and its reloads are intended for transection and resection of tissue and vasculature. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures.
    Device Description
    The Echelon Flex™ Powered Vascular Stapler with Advanced Placement Tip and ENDOPATH Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 Row) reloads are sterile, single patient use devices that simultaneously cut and staple tissue. There are four staggered rows of staples, two on either side of the cut line. The Echelon Flex Powered Vascular Stapler with Advanced Placement Tip and reloads have a staple line that is approximately 35 mm long and a cut line that is approximately 30 mm long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate access to the operative site. The instrument is packaged with a primary lithium battery pack that must be installed prior to use. The instrument is packaged without a reload and must be loaded prior to use. A staple retaining cap on the reload protects the staple leg points during shipping, transporting, and installing the reload. The instrument's lockout feature is designed to prevent a used or improperly installed reload from being refired or an instrument from being fired without a reload.
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    K Number
    K111195
    Device Name
    VALUTRUS REUSABLE CIRCULAR STAPLER AND DISPOSABLE RELOADS
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2011-08-03

    (97 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
    Device Description
    The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).
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    K Number
    K110385
    Device Name
    ECHELON FLEX 45 / 60 POWERED ARTICULATING ENDOSCOPIC LINEAR CUTTER
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2011-03-25

    (43 days)

    Product Code
    GDW, GAG
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ECHELON families of endoscopic linear cutters are intended for transection, resection, and/or creation of anastomoses. The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue buttressing materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
    Device Description
    The Echelon Flex Powered Articulating Endoscopic Linear Cutters are sterile, single patient use instruments that simultaneously cut and staple tissue through a battery powered firing system. The instruments deliver six staggered rows of staples, three on either side of the cut line. The instruments are available in three shaft lengths: compact, regular and long. The shaft can rotate freely in both directions and incorporates an articulation mechanism, which enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The instruments are packaged with a battery pack that must be installed prior to use. The instruments are shipped without a cartridge and must be loaded prior to use. The instrument has a safety lock-out feature that is designed to prevent an instrument without a cartridge or a used cartridge from being fired.
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    K Number
    K101520
    Device Name
    ENSEAL TISSUE SEALING DEVICES MODEL: NSEAL514H-535H, NSEAL514RH-535RH
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2010-12-10

    (191 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EnSeal LCJ Tissue Sealing Device is indicated for bipolar coagulation and mechanical transection of tissue during open procedures. It is a bipolar electrosurgical instrument for use with an electrosurgical generator. It is intended for use during open, general and gynecological surgery to cut and seal vessels, cut, grasp and dissect tissue during surgery. Indications for use include open, general, gynecological surgical procedures (including urologic, thoracic, plastic and reconstructive, bowel resections, hysterectomies, cholecystectomies, gall bladder procedures, Nissen fundoplication, adhesiolysis, oophorectomies, etc.), or any procedure where vessel ligation (cutting and sealing), tissue grasping and dissection is performed. The devices can be used on vessels up to (and including) 7 mm and bundles as large as will fit in the jaws of the instruments. The EnSeal Tissue Sealing Device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use this system for these procedures.
    Device Description
    The Ethicon Endo-Surgery EnSeal LCJ Tissue Sealer is a sterile, single patient use device. The functionality is the same as the predicate devices.
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    K Number
    K102632
    Device Name
    ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2010-10-07

    (24 days)

    Product Code
    GDW
    Regulation Number
    878.4750
    Why did this record match?
    Applicant Name (Manufacturer) :

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethicon Endo-Surgery® 5mm Laparoscopic Multi-Feed Stapler has application for use in a variety of minimally invasive procedures for approximation of tissue.
    Device Description
    The Ethicon Endo-Surgery 5mm Laparoscopic Multi-feed Stapler is a sterile, single patient use instrument designed for use with a 5mm diameter trocar. The device places rectangular titanium staples. The staple opens to a tip to tip width of about 6.1mm (0.240 inches). Closed staple dimensions are approximately 5.5 mm x 6.1 mm (0.215 inches x 0.242 inches). The instrument shaft is 5.5mm (0.218 inches) in diameter and 457mm (18 inches) long and contains about 40 staples.
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    K Number
    K093896
    Device Name
    ETHICON ENDO SURGERY SLOTTED ANOSCOPE
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2010-03-25

    (97 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EES Slotted Anoscope is intended for physician use to examine the anal sphincter and anus, and using additional accessories, to perform various diagnostic and therapeutic procedures.
    Device Description
    The Ethicon Endo Surgery® Slotted Anoscope consists of a transparent plastic disposable anoscope in sterile condition. The Slotted Anoscope comprises a cylindrical body, with a closed end conical-shaped distal tip and a longitudinal open channel that accommodates a removable slide. The removable slide comprises a longitudinal open channel of 11mm in width. The body of the Slotted Anoscope has an outer diameter (OD) of 34mm. The Slotted Anoscope is a single patient use device. The transparent characteristics of the material used in the Slotted Anoscope allows for visualization of the tissue in contact with the device in the anal canal. The opening in the removable slide provides access to tissue in the canal. The removal of the slide provides a wider margin of access to the targeted area.
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    K Number
    K091259
    Device Name
    ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2010-01-15

    (261 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are intended for use in endoscopic procedures where fusion of vessels or tissue bundles is performed. The device can be used on vessels up to 3 mm and bundles as large as will fit in the jaws of the instrument. The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. It is not recommended for use with other manufacturer's generators.
    Device Description
    The Ethicon Endo-Surgery® Flexible Bipolar Hemostasis Forceps Device Description is a sterile, single-use device intended for use in endoscopic procedures where fusion of The device can be used on vessels up to 3 mm vessels or tissue bundles is performed. and bundles as large as will fit in the jaws of the instrument. A vessel fusion is created by the application of bipolar electrosurgical RF energy (coagulation) to the vessels placed between the jaws of the instrument. The Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps sources RF energy from an electrosurgical generator. Specifically, the Ethicon Endo-Surgery Flexible Bipolar Hemostasis Forceps are designed for use with an ERBE VIO 300 D Electrosurgical Generator (ESU) System. This device passes through endoscopes having a 3.7 mm or larger working channels.
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    K Number
    K091824
    Device Name
    ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2009-11-27

    (161 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
    Device Description
    The Ethicon Endo Surgery (EES) Rotating Endoscopic Scissors are a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The Rotating Endoscopic Scissors are a sterile, single patient use, disposable instrument consisting of a flexible wire cable and scissors end effector. The end effector can be rotated independently of the shaft. When connected to an electrosurgical generator using a 4.5 mm monopolar cable (not supplied) and activated, the Rotating Scissors delivers a monopolar electrical current to the surgical site. This device passes through gastroscopes having a 2.8 mm or larger working channels. This device is supplied sterile for single-patient use.
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    K Number
    K093236
    Device Name
    ETHICON ENDO-SURGERYOPTICAL DILATOR
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2009-11-10

    (26 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
    Device Description
    The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical Dilator to allow for visualization at the stricture site.
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    K Number
    K091290
    Device Name
    ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Date Cleared
    2009-10-29

    (181 days)

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

    ETHICON ENDO-SURGERY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures.
    Device Description
    The Ethicon Endo Surgery® (EES) Rotating Hook Knife is a monopolar electrosurgical instrument intended for cutting, dissecting and cauterizing soft tissue during endoscopic electrosurgical procedures. The device consists of a flexible wire cable and hook knife electrode, which can be extended and rotated from the flexible outer shaft using two handle control knobs. When connected to an electrosurgical generator and activated, the hook knife delivers a monopolar electrical current to the surgical site. This device passes through endoscopes having a 2.8 mm or larger working channel. This device is supplied sterile for single-patient use.
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