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510(k) Data Aggregation

    K Number
    K231277
    Device Name
    TissueStat
    Manufacturer
    DuraStat LLC
    Date Cleared
    2023-11-09

    (190 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TissueStat PTFE (polytetrafluroethylene) Suture and Delivery Device is indicated for use in all types of soft tissue approximation and / or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. TissueStat PTFE Sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. TissueStat PTFE Sutures are provided sterile as a single use device.
    Device Description
    The TissueStat PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are available uncoated and undyed in USP size 2/0. The sutures are attached to standard stainless steel surgical needles. The TissueStat Suture Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Suture Delivery Device and is delivered to the desired location through the device tip by pressing the actuation button on the device handle.
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    K Number
    K192088
    Device Name
    GOLNIT Non-aborbable PTFE Surgical Suture
    Manufacturer
    Antarma LLC dba Golnit Sutures
    Date Cleared
    2019-09-04

    (30 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GOLNIT Non-Absorbable PTFE Surgical Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental, cardiovascular and general surgeries, as well as repair of the dura mater. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
    Device Description
    The GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0. The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple. The final configuration of the GOLNIT Non-absorbable PTFE Surgical Suture consists of specified length and diameters of PTFE monofilaments with attached standard, medical grade suture needles. The suture is packaged into a labelled two-pouch packaging system consisting of medical grade heat-sealable pouches. The GOLNIT Non-absorbable PTFE Surgical Suture is sterilized by ethylene oxide and is intended for single use only.
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    K Number
    K180992
    Device Name
    Biotex
    Manufacturer
    Purgo Biologics Inc.
    Date Cleared
    2019-07-16

    (456 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Biotex Non-Absorbable PTFE Suture is indicated for use in dental soft tissue approximation and/or ligation. The device is not indicated for use in cardiovascular, ophthalmic surgery, microsurgery or peripheral neural tissue. Biotex is provided sterile as a single use device and the duration of use or contact with the body is less than 30 days.
    Device Description
    Biotex Non-Absorbable PTFE Suture is comprised of a single-arm, non-absorbable monofilament suture and the stainless-steel surgical needle connected to the suture. It is composed of 100% high-density PTFE provided uncoated, undyed and sterile for one-time use only.
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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?
    Product Code :

    NBY

    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
    K181578
    Device Name
    DemeTECH PTFE Nonabsorbable Surgical Suture
    Manufacturer
    Demetech Corporation
    Date Cleared
    2018-10-11

    (118 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DemeTECH PTFE Suture is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery, and peripheral neural tissue.
    Device Description
    DemeTECH PTFE Suture is a nonabsorbable, sterile surgical monofilament suture composed of polytetrafluoroethylene. The DemeTECH PTFE Suture meets or exceeds all requirements in the latest edition of the USP monograph for nonabsorbable surgical sutures and is provided sterile in various sizes and configurations. The material is undyed and contains no additives and is white in appearance and may be provided with or without an attached needle(s).
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    K Number
    K180630
    Device Name
    PTFE SURGICAL SUTURE
    Manufacturer
    OMNIA SPA
    Date Cleared
    2018-04-06

    (28 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PTFE SURGICAL SUTURE is indicated for use in all types of soft tissue approximation and/or ligation, including dental and general surgeries. The device is not indicated for use in cardiovascular surgery, ophthalmic surgery, and neural tissue.
    Device Description
    PTFE SURGICAL SUTURE
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    K Number
    K173922
    Device Name
    C-PTFETM Surgical Suture
    Manufacturer
    CP Medical Inc.
    Date Cleared
    2018-03-26

    (90 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.
    Device Description
    The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014
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    K Number
    K173335
    Device Name
    Gazelle PTFE and Suture Delivery Device
    Manufacturer
    Dura Tap LLC
    Date Cleared
    2018-02-08

    (108 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GazelleTM PTFE (polytetrafluroethylene) suture and Delivery Device is indicated for use in general soft tissue approximation and/or ligation, including; cardiovascular, dental, general surgical procedures and repair of the dura mater. Gazelle™PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. GazelleTM PTFE suture and Delivery Device is provided sterile as a single use device.
    Device Description
    The Gazelle PTFE surgical sutures are monofilament surgical sutures composed from expanded polytetrafluoroethylene (ePTFE) material. They are attached to a standard stainless steel surgical needle. The Gazelle Delivery Device is a Class I Manual Surgical Instrument that assists with suture placement. The PTFE suture is loaded into the Gazelle Delivery Device and is delivered to the desired location through the Gazelle device tip by pressing the actuation button on the Gazelle device handle.
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    K Number
    K170842
    Device Name
    WEGO-PTFE
    Manufacturer
    Foosin Medical Supplies Inc., Ltd.
    Date Cleared
    2017-07-31

    (132 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue.
    Device Description
    The proposed device, WEGO-PTFE, is monofilament, synthetic, non-absorbable surgical suture composed of 100% polytetrafluoroethylene without any additives. The molecular formula is (C-F2)n. WEGO-PTFE is undyed and uncoated. The proposed device is composed of suture and needle. WEGO-PTFE is indicated for use in all types of soft tissue approximation and/or ligation, including cardiovascular, dental and general surgeries. The device is not indicated for use in ophthalmic surgery, microsurgery and peripheral neural tissue. The sutures are available in a range of gauge sizes and lengths attached to stainless steel needles of varying types and sizes. WEGO-PTFE complies with the requirements of the European Pharmacopoeia for Sterile Non-Absorbable Strands and the requirements of the United States Pharmacopoeia for Non-Absorbable Surgical Sutures.
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    K Number
    K163049
    Device Name
    GOLNIT Non-Absorbable PTFE Surgical Suture
    Manufacturer
    Antarma dba Golnit Sutures
    Date Cleared
    2017-06-21

    (232 days)

    Product Code
    NBY
    Regulation Number
    878.5035
    Why did this record match?
    Product Code :

    NBY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes.
    Device Description
    GOLNIT Non-absorbable PTFE Surgical Suture is a sterile, disposable, non-absorbable suture that meets the requirements of the United States Pharmacopeia (U.S.P.) except for diameter. The suture is manufactured of a 100% polytetrafluoroethylene (PTFE) polymer as monofilament strands that are uncoated, undyed, and of various diameters and lengths that may be crimped or swaged to a standard, medical grade suture needle. The suture sizes range from U.S.P. 2-0 to 6-0. The surgical suture incorporates a monofilament manufactured from 100% virgin polytetrafluoroethylene (PTFE) resin that is extruded as an expanded porous (ePTFE) monofilament that is soft and supple. GOLNIT Non-Absorbable PTFE Surgical Suture is sterilized by ethylene oxide. The GOLNIT surgical suture is intended for single use only. The surgically invasive device is indicated to remain in the body for up to 30 days and is biocompatible. GOLNIT Non-Absorbable PTFE Surgical Suture is a removable, non-absorbable surgical suture intended for use in the approximation and ligation of soft tissue in the oral cavity including fixation of barrier membranes. The device is not intended for invasive procedures related to central nervous system and central circulatory system.
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