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510(k) Data Aggregation

    K Number
    K221527
    Device Name
    StitchKit
    Manufacturer
    Origami Surgical Inc .
    Date Cleared
    2023-02-14

    (264 days)

    Product Code
    GAM, GAT, GCJ, NAY
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origami Surgical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
    Device Description
    StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.
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    K Number
    K211792
    Device Name
    StitchKit
    Manufacturer
    Origami Surgical Inc .
    Date Cleared
    2021-07-16

    (36 days)

    Product Code
    GAM, GAT, GCJ, NAY
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origami Surgical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
    Device Description
    StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.
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    K Number
    K202950
    Device Name
    StitchKit COMBO
    Manufacturer
    Origami Surgical
    Date Cleared
    2021-02-23

    (146 days)

    Product Code
    GAM, GAP, GCJ, NAY
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origami Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the StitchKit® device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
    Device Description
    StitchKit® COMBO is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch. Each StitchKit® version contains strands of existing legallymarketed Suturing Materials, cleared for use within the StitchKit®.
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    K Number
    K191317
    Device Name
    StitchKit
    Manufacturer
    Origami Surgical
    Date Cleared
    2019-07-12

    (58 days)

    Product Code
    NBY, GCJ, NAY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origami Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.
    Device Description
    StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles.
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    K Number
    K173874
    Device Name
    StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
    Manufacturer
    Origami Surgical LLC
    Date Cleared
    2018-05-04

    (134 days)

    Product Code
    GAM, GCJ, NAY, NEW
    Regulation Number
    878.4493
    Why did this record match?
    Applicant Name (Manufacturer) :

    Origami Surgical LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch. Each StitchKit® version contains strands of existing legally-marketed Suturing Materials. The subject StitchKit® versions contain: - StitchKit® V-Loc™90: Contains Covidien V-Loc™90 Wound Closure -Devices - -StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices - -StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures
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    K Number
    K142639
    Device Name
    StitchKit
    Manufacturer
    ORIGAMI SURGICAL LLC
    Date Cleared
    2014-12-16

    (90 days)

    Product Code
    GAW, GCJ, NAY
    Regulation Number
    878.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGAMI SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.
    Device Description
    The StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture ("StitchKit") is a sterile, single-use plastic canister that is pre-loaded with multiple strands of legally marketed monofilament polypropylene surgical suture (with needles attached). The device facilitates robotic-assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once. The surgeon can then dispense the suture strands one at a time. The device is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, used needles are deposited into a compartment within the StitchKit® canister. Once the surgeon has finished suturing, the device is removed along with the used needles inside. It is supplied sterile in a plastic tray with Tyvek® lid.
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    K Number
    K123811
    Device Name
    STITCHKIT
    Manufacturer
    ORIGAMI SURGICAL LLC
    Date Cleared
    2013-09-05

    (268 days)

    Product Code
    NBY, GCJ, NAY
    Regulation Number
    878.5035
    Why did this record match?
    Applicant Name (Manufacturer) :

    ORIGAMI SURGICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StitchKit® is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastomotic procedures is desired.
    Device Description
    The StitchKit® device is a sterile, single-use plastic canister that is pre-loaded with six strands of non-USP ePTFE suture, (diameter approx. 0.294 mm < dia <0.383 mm, and strand length approx. 20 cm). The device facilitates robotically assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once within the plastic canister. The surgeon can then retrieve the suture strands from the canister one at a time. The device is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, used needles are deposited into a compartment within the StitchKit® canister. Once the surgeon has finished all suturing, the device is removed with the used needles still inside. It is supplied sterile in a plastic tray with Tvvek® lid.
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