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510(k) Data Aggregation

    K Number
    K141625
    Device Name
    POLYSYN SURGICAL SUTURE
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Date Cleared
    2014-07-18

    (31 days)

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

    SURGICAL SPECIALTIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    POLYS YN™ Polyglycolic Acid (PGA) Suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in Cardiovascular and Neurological procedures.
    Device Description
    PGA Sutures are supplied as braided or monofilament, dyed (violet) or undyed and coated or uncoated. The pigment for the violet is D&C Violet #2. Where applicable, the coating is a copolymer of polycarpolactone and calcium stearate. The PGA Suture is available in Size 2 through Size 10-0.
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    K Number
    K141558
    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Date Cleared
    2014-07-11

    (29 days)

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

    SURGICAL SPECIALTIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ MONODERM™ device is indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate.
    Device Description
    The Quill™ Monoderm™ Knotless Tissue-Closure Device is a sterile, synthetic absorbable tissue approximation device that is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Sizes 0 to 5-0, in various lengths affixed to various needle types.
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    K Number
    K140227
    Device Name
    MONODERM SURGICAL SUTURE
    Manufacturer
    SURGICAL SPECIALTIES CORP.
    Date Cleared
    2014-02-28

    (29 days)

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

    SURGICAL SPECIALTIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MONODERM™ (PGA-PCL) suare is indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.
    Device Description
    Monoderm™ (PGA-PCL) suture is a monofilament synthetic absorbable surgical suture prepared from a copolymer of glycolide and e-carpolactone. The Monoderm™ (PGA-PCL) suture is available dyed and undyed in Size 1 through Size 6-0.
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    K Number
    K133420
    Device Name
    TRANQUILL BARBED DEVICE
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2013-11-29

    (21 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TranQuill barbed device comprised of polydioxanone, is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The TranQuill barbed device is a sterile, synthetic absorbable device that is intended for use in the approximation of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The device is designed with small bi-directional barbs along the long axis of the suture monofilament. It is available in diameter Size 0 through 2-0 in various lengths affixed to various needle types.
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    K Number
    K131224
    Device Name
    SHARPOINT POLYPROPYLENE SURGICAL SUTURE, LOOK POLYPROPYLENE SURGICAL SUTURE, QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2013-05-16

    (16 days)

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

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Polypropylene suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures. Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
    Device Description
    The Polypropylene Surgical Suture and Quill™ Polypropylene Tissue-Closure Devices are sterile, synthetic Knotless nonabsorbable surgical suturing devices that are intended for use in the closure of soft tissue. They are comprised of high molecular weight, isotactic polypropylene, undyed, or dyed with Phthalocyaninato (2-) Copper. The proposed blue modification is a change in supplier of the polypropylene resin raw material. The devices are supplied either single or doublearmed with various needle types, and are available in USP diameter Sizes 2 through 11-0, as applicable. The Quill™ Polypropylene devices are designed with either small opposing bi-directional or uni-directional barbs along the long axis of the suture monofilament. The uni-directional products contain a welded primary loop and secondary loop design at the distal end, opposite the attached needle.
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    K Number
    K130078
    Device Name
    QUILL POLYPROPYLENE KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2013-02-28

    (45 days)

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

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ Knotless Tissue-Closure Device comprised of Polypropylene is indicated for soft tissue approximation excluding closure of the epidermis.
    Device Description
    The Quill™ Polypropylene Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic nonabsorbable tissue-closure device that is intended for use in the closure of soft tissue, excluding closure of the epidermis. It is comprised of high molecular weight, isotactic polypropylene, undyed, or dyed blue with Phthalocyaninato (2-) Copper. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0 in various lengths affixed to various needle types.
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    K Number
    K123877
    Device Name
    QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2013-01-02

    (16 days)

    Product Code
    NEW
    Regulation Number
    878.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuillTM PDO Knotless Tissue-Closure Device comprised of Polydioxanone is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The QuillTM PDO Knotless Tissue-Closure Device, Variable Loop Design (Polydioxanone) is a sterile, synthetic absorbable tissue- closure device that is intended for use in the closure of soft tissue. It is comprised of polyester [poly (p-dioxanone)], dyed with D&C Violet No. 2. The instrument is designed with small uni- directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 0, 2-0 and 3-0 in various lengths affixed to various needle types.
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    K Number
    K123836
    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2012-12-21

    (8 days)

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

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The QuillTM MonodermTM Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 1 to 3-0, in various lengths affixed to various needle types.
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    K Number
    K123409
    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2012-11-20

    (15 days)

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

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The Quill <sup>TM</sup> Monoderm <sup>TM</sup> Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone, undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Sizes 2-0 to 0 in various lengths affixed to various needle types.
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    K Number
    K122898
    Device Name
    QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN
    Manufacturer
    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH
    Date Cleared
    2012-10-22

    (31 days)

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

    SURGICAL SPECIALTIES CORP. DBA ANGIOTECH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Quill™ Knotless Tissue-Closure Device comprised of Monoderm™ is indicated for soft tissue approximation where use of an absorbable suture is appropriate.
    Device Description
    The Quill™ Monoderm™ Knotless Tissue-Closure Device, Variable Loop Design is a sterile, synthetic absorbable tissue-closure device that is intended for use in the closure of soft tissue. It is comprised of a copolymer of glycolide and e-caprolactone. undyed, or dyed with D&C Violet No. 2. The device is designed with small uni-directional barbs along the long axis of the suture monofilament which contains a welded primary loop and secondary loop design at the distal end. It is available in diameter Size 2-0 in various lengths affixed to various needle types.
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