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510(k) Data Aggregation

    K Number
    K101534
    Device Name
    CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM
    Manufacturer
    CONMED CORP.
    Date Cleared
    2010-11-24

    (174 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONMED ALTRUS® Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired.
    Device Description
    The CONMED Altrus Thermal Tissue Fusion system consists of the following: - CONMED Altrus Thermal Tissue Fusion Energy Source . - CONMED Altrus Thermal Tissue Fusion Handpiece. . The CONMED Altrus Thermal Tissue Fusion system employs focused thermal energy and pressure to simultaneously seal and/or seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the ConMed Altrus products can reduce the potential of unintended thermal injury. The energy source uses an LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows for the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature, by means of simple resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal) The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software. The CONMED Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas. Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication to and from the handpiece.
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    K Number
    K061021
    Device Name
    ENTAKE STANDARD AND SAFETY PEG SYSTEM
    Manufacturer
    CONMED CORP.
    Date Cleared
    2006-04-28

    (15 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For percutaneous placement of a long-term initial-placement feeding and/or decompression device.
    Device Description
    The EnTake PEG Standard and Safety System contains a gastrostomy feeding tube, external retention bolster, two-port feeding adapter, feeding tube clamp packaged sterile in a kit containing procedural aides. The EnTake PEG System consist of both standard and safety kits in both push and pull versions. Standard kits contain the components that are typically used in the procedure. Safety kits contain alternative safety versions of the scalpel, the needle introducer and the 5 cc syringe. The EnTake PEG System will be offered in a variety of sizes and variations that allow for installation via guidewire (push) or pull wire, placement in a new gastrostomy.
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    K Number
    K050992
    Device Name
    CONMED IRRIGATION NOZZLE
    Manufacturer
    CONMED CORP.
    Date Cleared
    2005-07-14

    (86 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.
    Device Description
    The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.
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    K Number
    K050777
    Device Name
    PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907
    Manufacturer
    CONMED CORP.
    Date Cleared
    2005-04-22

    (25 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system.
    Device Description
    The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage. Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.
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    K Number
    K050304
    Device Name
    FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
    Manufacturer
    CONMED CORP.
    Date Cleared
    2005-03-08

    (28 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.
    Device Description
    The FXWire™ Advanced Measurement Guidewire is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The guidewire has a flexible radiopaque tip, with a hydrophilic coating for enhanced lubricity. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. Additionally, at the proximal end of the guidewire, endoscopic marker bands have been placed beginning at 210cm and extending to 270cm from the distal tip of the guidewire. These marker bands enable endoscopic and fluoroscopic visualization of movement, as well as estimation of stricture length. This guidewire meets the recognized standard for high frequency current leakage (Reference ANSI/AAMI Standard HF 18-1993) when used with a sphinctertome and may be left in place during electrosurgical cutting.
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    K Number
    K041953
    Device Name
    VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
    Manufacturer
    CONMED CORP.
    Date Cleared
    2004-08-09

    (20 days)

    Product Code
    GXY
    Regulation Number
    882.1320
    Why did this record match?
    Applicant Name (Manufacturer) :

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For TENS and Neuromuscular Stimulation
    Device Description
    Not Found
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    K Number
    K021079
    Device Name
    ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-07-01

    (89 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.
    Device Description
    Not Found
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    K Number
    K021299
    Device Name
    CONMED HEATWAVE HAND-CONTROLLED ELETRODE
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-06-26

    (63 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.
    Device Description
    Not Found
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    K Number
    K020135
    Device Name
    CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF: 60-6120
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-04-12

    (87 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.
    Device Description
    Not Found
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    K Number
    K020186
    Device Name
    CONMED SYSTEM 5000 ESU
    Manufacturer
    CONMED CORP.
    Date Cleared
    2002-04-12

    (84 days)

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

    CONMED CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of any FF (radio frequency) electrosurgical current through an accessor selectrode for cutting and coagulation at the operative site.
    Device Description
    Not Found
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