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510(k) Data Aggregation

    K Number
    K241150
    Device Name
    MISTI Silicone Implant
    Manufacturer
    Keosan Trading Co.
    Date Cleared
    2024-07-24

    (90 days)

    Product Code
    MIB, FWP, FZE, LZK, MIC
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MISTI Silicone Implant is intended for the augmentation of the nasal, malar, chin, gluteal, calf and/or pectoral contour.
    Device Description
    The MISTI Silicone Implant offers various types including Nasal, Chin, Mid-face, Forehead, Block, Temple, Gluteal, Calf and Pectoral. The Nasal, Chin, Mid-face, Forehead, Gluteal, Calf and Pectoral are used for the areas indicated in the type names. The Block type is used for various areas during plastic and reconstruction surgeries. The Temple type can be used on a juncture where four skull bones fuse together so called the temple region. It is made of implant grade silicone elastomer, and the design characteristic minimizes carving and promotes natural line.
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    K Number
    K223051
    Device Name
    Pre-Formed Silicone Block
    Manufacturer
    International Medical Devices, Inc.
    Date Cleared
    2023-02-03

    (127 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process.
    Device Description
    The Pre-Formed Silicone Block is an implant intended to be used in the aesthetic (cosmetic) correction of soft tissue deformities. The Pre-Formed Silicone Block comes in multiple shapes and sizes (cup-shaped in small, medium and large; crescent-shaped, and rectangular block) and one durometer to accommodate a variety of surgical techniques and implantation sites. All implants are made from medical grade silicone and can be trimmed with a knife or scissors. The trimmable feature allows the surgeon to custom fabricate, at surgery, an implantable implant for a specific surgical indication. The implants are provided either sterile or non-sterile. Devices that are provided non-sterile must be sterilized prior to use.
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    K Number
    K222748
    Device Name
    ShiNeo Silicone Implant
    Manufacturer
    Shineo Technology Co., Ltd
    Date Cleared
    2022-12-23

    (102 days)

    Product Code
    MIB, FWP, LZK
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ShiNeo Silicone Implant is intended for the augmentation of the nasal and/or chin contour
    Device Description
    ShiNeo Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The ShiNeo Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The ShiNeo Silicone Implant is individually packaged and sterilized by gamma radiation and is labeled for single use. ShiNeo Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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    K Number
    K200073
    Device Name
    AugMENTA Penile Implant
    Manufacturer
    Augmenta LLC
    Date Cleared
    2022-09-30

    (990 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Augmenta Penile Implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant.
    Device Description
    The Augmenta Penile Implant is an implantable device intended for use in the cosmetic correction of soft tissue deformities, and is trimmed to length at the surgeon's discretion for a custom implant. The Augmenta Penile Implant is made of silicone. The Augmenta Penile Implant comes in 175 sizes with a range of dimensions. The proximal end of the device may be trimmed by the physician to further customize the fit. The device is provided sterile and is intended for single-use only.
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    K Number
    K220760
    Device Name
    Pre-Formed Penile Silicone Block
    Manufacturer
    International Medical Devices, Inc.
    Date Cleared
    2022-05-13

    (59 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed Penile Silicone Block is intended for use in augmentation, reconstructive and cosmetic surgery, and is contoured at the surgeon's discretion to create a custom implant. When used in augmentation procedures, the device provides cosmetic augmentation of the penis and is intended for aesthetic purposes.
    Device Description
    The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in visual augmentation, reconstructive and cosmetic surgery for the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
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    K Number
    K193392
    Device Name
    BioSiCar Silicone Implant
    Manufacturer
    Metalware Technology Corp.
    Date Cleared
    2020-07-20

    (227 days)

    Product Code
    MIB, FWP, LZK
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BioSiCar Silicone Implant is intended for the augmentation of the nasal and/or chin contour.
    Device Description
    BioSiCar Silicone Implant is a silicone implant used in facial surgery as nasal and/or chin implants. The BioSiCar Silicone Implant offers two major shapes to meet the needs in nasal and chin locations. The devices are also provided in various sizes and can be carved or cut to fit each patient. The BioSiCar Silicone Implant is individually packaged and sterilized by gamma radiation, and is labeled for single use. BioSiCar Silicone Implant is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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    K Number
    K181387
    Device Name
    Pre-Formed Penile Silicone Block
    Manufacturer
    International Medical Devices, Inc.
    Date Cleared
    2019-01-23

    (243 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
    Device Description
    The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
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    K Number
    K171851
    Device Name
    SOFTXIL
    Manufacturer
    BISTOOL
    Date Cleared
    2018-03-16

    (268 days)

    Product Code
    MIB, FWP, LZK
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SOFTXIL is intended for the augmentation or reconstruction of the nasal, malar, and or chin contour.
    Device Description
    SOFTXIL is injection molded silicone implants used in facial surgery as nasal, paranasal, and chin implants. The SOFTXIL offers various shapes to meet the needs in different locations. The devices are also provided in various sizes. The SOFTXIL is individually packaged and sterilized by ethylene oxide, and is labeled for single use. It has smooth surface with tapered ends. SOFTXIL is ideal for use in soft tissue augmentation where the use of a soft silicone elastomer is appropriate.
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    K Number
    K162624
    Device Name
    Pre-Formed Penile Silicone Block
    Manufacturer
    INTERNATIONAL MEDICAL DEVICES, INC.
    Date Cleared
    2017-02-01

    (134 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pre-Formed Penile Silicone Block is intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant.
    Device Description
    The Pre-Formed Penile Silicone Block is made from medical grade silicone with an embedded polyester mesh. The device comes in variations that include three sizes (L, XL, and XXL) and one durometer ("Soft"). Size "L" is 12 cm in length with a maximum thickness of 0.5 cm and a height of 2 cm. Size "XL" is 15 cm in length with a maximum thickness of 0.8 cm and a height of 3 cm. Size "XXL" is 18 cm in length with a maximum thickness of 1.1 cm and a height of 3.5 cm. The device is used in the cosmetic correction of soft tissue deformities in the penis, and may be trimmed to allow the surgeon to tailor the device to the needs of a specific patient.
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    K Number
    K052504
    Device Name
    GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X
    Manufacturer
    IMPLANTECH ASSOCIATES INC.
    Date Cleared
    2005-11-04

    (52 days)

    Product Code
    MIB
    Regulation Number
    874.3620
    Why did this record match?
    Product Code :

    MIB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Gluteal Implants (Silicone Carving Blocks) are for augmentation and reconstructive surgery. The Implantech Gluteal Implants are carvable to allow the surgeon to shape the device should additional shaping be desired.
    Device Description
    Gluteal Implants (Silicone Carving Blocks)
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