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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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