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    K Number
    K061544
    Device Name
    STELLARTECH 100 COAGULATION SYSTEM
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2006-10-13

    (130 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.
    Device Description
    The Stellartech 100 Coagulation System consists of the following components. - Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 . - . Stellartech 101 Probe - Optional Stellartech Footswitch. . The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.
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    K Number
    K050831
    Device Name
    STELLARTECH COAGULATION SYSTEM 2, MODELS 1100C-115A AND 1100C-230A
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2005-04-12

    (11 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System 2 consists of the following components. - . Stellartech Coagulation Catheter 2 - Stellartech Coagulation Generator 2 . - . Stellartech Catheter Connection Cable 2 - Optional Stellartech Sheath ● - Optional Stellartech Footswitch 2. . - Optional Stellartech Sizing Catheter 2 . The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.
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    K Number
    K042909
    Device Name
    STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115A & 1100C-230A
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2004-11-12

    (22 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Catheter . - Stellartech Coagulation Catheter Connection Module . - Stellartech Coagulation Generator . - . Stellartech Sheath - . Optional Stellartech Footswitch. - . Optional Stellartech Sizing Catheter - Optional Stellartech Sizing Sheath . The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K041383
    Device Name
    STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2004-06-14

    (20 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Catheter . - Stellartech Coagulation Catheter Connection Module t - . Stellartech Coagulation Generator - Stellartech Sheath . - Optional Stellartech Footswitch. . - Optional Stellartech Sizing Catheter . - Optional Stellartech Sizing Sheath . The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K040240
    Device Name
    STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2004-04-01

    (58 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophaqus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Catheter . - Stellartech Coagulation Catheter Connection Module ● - Stellartech Coagulation Generator . - Stellartech Sheath . - Optional Stellartech Footswitch. ◆ - Optional Stellartech Pressure Gauge - Optional Stellartech Sizing Catheter . - 후 Optional Stellartech Sizing Sheath The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of the Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K032721
    Device Name
    MODIFICATION TO: STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2003-10-06

    (33 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator . - Stellartech Probe Connection Module . - Stellartech Coagulation Probe . - Optional Accessory Stellartech Sizing Probe . - . Optional Stellartech Footswitch. The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Probe Connection Module. The proximal end of the Stellartech Probe Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K032452
    Device Name
    MODIFICATION TO: STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 & 100C-230
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2003-08-21

    (10 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator ● - Stellartech Coagulation Probe Connection Module ● - Stellartech Coagulation Probe ● - Optional Stellartech Sizing Probe . - Optional Stellartech Footswitch. . The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K032062
    Device Name
    STELLARTECH COAGULATION SYSTEM, MODELS (1100C-115 & 1100C-230)
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2003-07-29

    (26 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator ● - Stellartech Coagulation Probe Connection Module ● - Stellartech Coagulation Probe . - Optional Stellartech Footswitch. . The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K023765
    Device Name
    STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2002-11-29

    (17 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator . - Stellartech Coagulation Probe Connection Module ● - Stellartech Coagulation Probe . - Optional Stellartech Footswitch. . The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
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    K Number
    K013139
    Device Name
    STELLARTECH COAGULATION SYSTEM
    Manufacturer
    STELLARTECH RESEARCH CORP.
    Date Cleared
    2001-12-18

    (90 days)

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

    STELLARTECH RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
    Device Description
    The Stellartech Coagulation System consists of the following components. - Stellartech Coagulation Generator ● - Stellartech Coagulation Probe Connection Module . - Stellartech Coagulation Probe . - Optional Stellartech Footswitch. ● The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.
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