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510(k) Data Aggregation

    K Number
    K231012
    Device Name
    CoolSeal Trinity
    Date Cleared
    2023-11-15

    (219 days)

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

    Bolder Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, oophorectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
    Device Description
    The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft, is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 shaft lengths: 30 cm, 37 cm, and 44 cm.
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    K Number
    K211579
    Device Name
    CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)
    Date Cleared
    2021-09-07

    (109 days)

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

    Bolder Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on vessels (arteries, veins, and vascular bundles) up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). Procedures may include, but are not limited to, Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, etc. The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
    Device Description
    The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.
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    K Number
    K203183
    Device Name
    CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)
    Date Cleared
    2021-05-06

    (191 days)

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

    Bolder Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. It is indicated for use in adult and pediatric populations (infants, children, and adolescents). The CoolSeal™ Trinity has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. The device is contraindicated for use in ENT procedures.
    Device Description
    The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm.
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    K Number
    K203640
    Device Name
    CoolSeal Reveal
    Date Cleared
    2021-05-06

    (143 days)

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

    Bolder Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CoolSeal™ Reveal is a bipolar electrosurgical instrument intended for use in open surgical procedures in adults and pediatrics where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Reveal can be used on vessels (arteries and veins) up to and including 6 mm in diameter. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedures may include but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis. The CoolSeal™ Reveal is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, and parotidectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands. The CoolSeal™ Reveal has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the CoolSeal™ Reveal for these procedures.
    Device Description
    The CoolSeal™ Reveal device is a sterile, single-use, hand-held bipolar vessel sealing device designed for use with the CoolSeal™ Generator. The CoolSeal™ Reveal is a hemostat-style design with a 5 mm shaft diameter and 10 cm shaft length. The jaw is a curved Maryland-style jaw that rotates. The Reveal creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure.
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    K Number
    K202114
    Device Name
    CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20
    Date Cleared
    2020-10-06

    (68 days)

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

    Bolder Surgical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CoolSeal™ Trinity: The CoolSeal™ Trinity is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The CoolSeal™ Trinity can be used on arteries up to and including 6 mm, veins, and vascular bundles up to and including 7 mm in diameter. It is indicated for use in general surgery procedures including urologic, vascular, and gynecologic. The CoolSeal™ Trinity has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures. Do not use the CoolSeal™ Trinity for these procedures. CoolSeal™ Mini: The CoolSeal™ Mini is intended for use in open and laparoscopic general surgical procedures to seal blood vessels and vascular bundles up to and including 5 mm in diameter for use in adult and pediations, wherever vessel ligation is required. The device is contraindicated for use in ENT procedures. CoolSealTM Generator: The CoolSeal™ Generator is intended to provide Radio Frequency (RF) energy to compatible CoolSeal™ instruments for vessel-sealing applications. The specific application will depend on the compatible surgical device that is connected to the generator. This generator is designed to be used with only surgical devices compatible with the CoolSeal™ technology.
    Device Description
    CoolSeal™ Generator: The CoolSeal™ Generator is a non-sterile, reusable device used outside the sterile field. The generator is designed to provide lower power bipolar Radio Frequency (RF) energy to CoolSeal™ vessel sealing devices for tissue-sealing applications. CoolSeal™ Trinity: The CoolSeal™ Trinity, a Maryland Laparoscopic Sealer, Divider, and Dissector, with a 5 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Trinity is provided sterile and is a single-use disposable instrument. The Trinity creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between its jaws. A blade within the instrument is surgeon-actuated to divide tissue. The double action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Trinity includes 3 different shaft lengths: 30 cm, 37 cm, and 44 cm. CoolSeal™ Mini: The CoolSeal™ Mini a Maryland Jaw Sealer, with a 3 mm diameter shaft is designed for use with the CoolSeal™ Generator or any generator with the CoolSeal™ technology. The Mini is provided sterile and is a single-use disposable instrument. The Mini creates seals by application of radiofrequency (RF) electrosurgical energy to vascular structures or tissue bundles interposed between its jaws. The double-action jaws have been designed to dissect tissue, which includes separating tissue planes and widening openings as necessary for the surgical procedure. The CoolSeal™ Mini is only available in one shaft length: 20 cm.
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