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510(k) Data Aggregation

    K Number
    K001440
    Device Name
    NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    2000-11-13

    (189 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001434
    Device Name
    'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    2000-06-12

    (35 days)

    Product Code
    GAT
    Regulation Number
    878.5000
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K992088
    Device Name
    BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1999-09-03

    (74 days)

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

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bondek Plus Synthetic Absorbable Surgical 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
    Bondek Plus Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid. The suture material is coated with a copolymer of polycaprolactone and polyglycolic acid.
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    K Number
    K991416
    Device Name
    ENDOSCOPIC CAMERA
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1999-07-20

    (88 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are intended to attach to standard commercially available endoscopes for visualization of body cavities, hollow organs, and canals.
    Device Description
    The Genzyme Surgical Products Digital RGB and 3-Chip Digital RGB Endoscopic Cameras are designed to provide a picture of the surgical field during endoscopic procedures. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras take the image that would be normally seen by the naked eye, and displays it on a color monitor. The Digital RGB and 3-Chip Digital RGB Endoscopic Cameras provide imaging through standard, commercially available, legally marketed endoscopes. The Digital RGB and the 3-Chip Digital RGB Endoscopic Cameras both consist of a Camera head, camera control box, and camera cable, camera cable connector soaking cap and coupler accessories. A coupler couples the camera head to the commercially available endoscope.
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    K Number
    K991191
    Device Name
    BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1999-06-22

    (75 days)

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

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Bondek Synthetic Absorbable Surgical 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
    Bondek Synthetic Absorbable Surgical Suture is a sterile, absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The suture material is coated with a polycaprolactone-glycerol monostearate solution.
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    K Number
    K990062
    Device Name
    SAPHLIFT
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1999-03-30

    (81 days)

    Product Code
    MDM, MDW
    Regulation Number
    878.4800
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold surgical instruments in a given position and to change that position immediately with one hand. The SAPHLIFT is a holding and manipulating arm for use in surgery which allows the operating team to hold manual surgical instruments and the SaphLite Retractor in a given position and to change that position immediately with one hand.
    Device Description
    The SAPHLIFT consists of three main components: an articulated arm that clamps to the rail of the surgical bed, an instrument holder, and a compressed gas supply to maintain the pneumatic pressure to hold the instrument in place. Ball joints in the articulated arm and instrument holder allow for a wide variety of instrument positions. Repositioning of the instrument is by means of a control lever that releases the pneumatic pressure when pressed and locks the instrument in place when released. The SAPHLIFT is reusable and is sterilized by steam autoclave.
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    K Number
    K982712
    Device Name
    RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1998-12-18

    (136 days)

    Product Code
    CAC
    Regulation Number
    868.5830
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Rapid Transfer Blood Bag is intended for use as a blood evacuation and reinfusion device for shed mediastinal and pleural drainage when used in conjunction with the Pleur-evac Continuous Reinfusion Autotransfusion Systems.
    Device Description
    The Rapid Transfer Blood Bag is a flexible vinyl bag with a rigid frame that can be expanded using an actuator handle to cause transfer of blood from a Continuous Reinfusion Autotransfusion System.
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    K Number
    K980016
    Device Name
    MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1998-08-07

    (217 days)

    Product Code
    MOP
    Regulation Number
    870.3935
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Genzyme Surgical Products Millennium Valve Introducer/Rotator Handle is indicated for use during open and minimally invasive cardiac valve surgeries. This instrument is indicated for surgical introduction and rotation of a Sulzer Carbomedics Low Profile Mitral Valve Sizer and Rotator.
    Device Description
    The Millennium Valve Introducer/Rotator Handle (Introducer/Rotator Handle) consists of a handle, flexible shaft, and tip. The Handle includes two knobs that control the orientation and position of the tip. The proximal knob tightens the cable that adjusts the tip between 0 and 90 degrees. The distal knob rotates the tip between 0 and 360 degrees.
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    K Number
    K981322
    Device Name
    CUTALON NYLON POLYAMIDE SURGICAL SUTURE
    Manufacturer
    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
    Date Cleared
    1998-07-07

    (88 days)

    Product Code
    GAR
    Regulation Number
    878.5020
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    "Cutalon" Nonabsorbable Polyamide Surgical Sutures are provided sterile and are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    "Cutalon" Nonabsorbable Polyamide Surgical Sutures are composed of the long-chain aliphatic polymers extruded Nylon (Nylon 6) sutures which conform to the United States Code of Federal Regulations, 21 CFR Part, 878.5020. "Cutalon" is a wet-packed, extruded, nylon monofilament suture. The base polymer material is Nylon 6. (As required in CFR 878.5020) The nylon suture material is foilpackaged "wet" in a solution containing isopropyl alcohol, water and other components. The purpose of the "wet" packaging is to provide a nylon suture that is supple (easier to twist and tie) straight from the package due to the water absorption into the nylon. Genzyme "Cutalon" Surgical Suture are available in USP sizes 6-0 through 0 (metric sizes 0.7 through 3.5).
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