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510(k) Data Aggregation

    K Number
    K240919
    Device Name
    Silk Voice (SMI-04)
    Manufacturer
    Sofregen Medical
    Date Cleared
    2024-05-03

    (30 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sofregen Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
    Device Description
    Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides longterm restoration and augmentation. Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.
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    K Number
    K180631
    Device Name
    Silk Voice
    Manufacturer
    Sofregen Medical, Inc.
    Date Cleared
    2018-11-08

    (244 days)

    Product Code
    MIX
    Regulation Number
    874.3620
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sofregen Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silk Voice® is indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. Silk Voice® injection augments the size of the displaced or deformed vocal fold so that it may meet the opposing fold at the midline for improved phonation. Vocal fold insufficiency associated with serious aspiration difficulties may be an urgent indication.
    Device Description
    Silk Voice® is a sterile, non-pyrogenic, cohesive implant provided in a prefilled syringe and is a ready to use product. Silk Voice is comprised of porous bioabsorbable silk particles suspended in an isotonic, aqueous formulation of cross-linked, high molecular weight hyaluronic acid (HA). The crosslinked HA gel acts as a carrier for the silk particles to facilitate delivery. The main component of Silk Voice is silk particles, manufactured exclusively from regenerated silk fibroin protein, isolated from purified, silk fibers. When injected, Silk Voice provides immediate volume augmentation to the vocal fold tissue. The porous particles remain at the site of implantation, providing a scaffold for local tissue infiltration. This cellular infiltrated silk scaffold provides the long term restoration and augmentation. Silk Voice prefilled syringes are provided in a kit with a catheter, that is designed for endoscopic delivery to the vocal fold. The catheter accessory provided in the kit is specifically designed for delivery of injectable materials into tissue during endoscopic procedures.
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    K Number
    K172545
    Device Name
    SERI Contour
    Manufacturer
    Sofregen Medical, Inc.
    Date Cleared
    2017-09-22

    (30 days)

    Product Code
    OXF
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sofregen Medical, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SERI® Contour is indicated for use as a transitory scaffold for soft tissue support and repair to reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery and general soft tissue reconstruction.
    Device Description
    SERI® Contour is a knitted, multifilament, bioengineered, long-term bioresorbable scaffold. It is derived from pure silk fibroin. The device is a mechanically strong and biocompatible protein mesh. SERI® Contour is a sterile, single use only product and is supplied in a variety of sizes. ready for use in open or laparoscopic procedures. The scaffold is flexible and well-suited for delivery through a laparoscopic trocar. It is tear resistant, with excellent suture retention, and can be cut in any direction. SERI® Contour provides immediate physical and mechanical stabilization of a tissue defect through its strength and porous (scaffold-like) construction.
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