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510(k) Data Aggregation

    K Number
    K031554
    Device Name
    S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM
    Manufacturer
    GENZYME BIOSURGERY
    Date Cleared
    2003-07-25

    (67 days)

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

    GENZYME BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use: AUTOTRANSFUSION 1) for the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations CHEST DRAINAGE - 1) to evacuate air and/or fluid from the chest cavity or mediastrinum - 2) to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum - 3) to help re-establish and maintain normal intrathoracic pressure gradients - 4) to facilitate complete lung re-expansion to restore normal breathing dynamic.
    Device Description
    The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a multi-chamber collection/reinfusion system. The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a sterile, single use devices intended for the collection of autologous blood (autotransfusion) and as chest drainage collection units.
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    K Number
    K030212
    Device Name
    MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
    Manufacturer
    GENZYME BIOSURGERY
    Date Cleared
    2003-03-27

    (65 days)

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

    GENZYME BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Monodek™ Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and opthalmic surgery. Monodek suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
    Device Description
    Monodek Absorbable Surgical Suture meets all USP requirements except for oversized diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture is a sterile, monofilament and is provided in a variety of lengths, with or without needles and may be supplied in a variety of cut lengths or on ligating reels.
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    K Number
    K022989
    Device Name
    RADLITE TISSUE RETRACTOR SYSTEM
    Manufacturer
    GENZYME BIOSURGERY
    Date Cleared
    2002-11-25

    (77 days)

    Product Code
    FSW
    Regulation Number
    878.4580
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENZYME BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tissue Retractor System is intended for use in dissecting and retracting in all types of surgical procedures requiring dissection and retraction of tissue. The RadLite™ Tissue Retractor System has application for the creation and maintenance of an operative cavity in the extraperitoneal spaces such as the retroperitoneal, preperitoneal and subcutaneous areas. The device may be used in all types of surgical procedures requiring retraction of tissue.
    Device Description
    The Genzyme Tissue Retractor System s is a surgical instrument that provides a means to create and maintain a cavity by retracting the subcutaneous layer to expose the conduit. The retraction is sufficient to allow enough exposure to dissect and retract subcutaneous tissue for performing all types of surgical procedures. This system consists of the following components: - Handle: The handle securely holds the retractor blade, light panel, and provides a host adaptor for ACMI connection to a variety of commercially available light sources. - Retractor/blade: The stainless steel retractor blade attaches to the handle for lifting the subcutaneous layer. - Fiber Optic Light Panel: The light panel fits securely into the handle on the underside of the retractor blade to provide illumination for the procedure.
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    K Number
    K022410
    Device Name
    SAPH-LOOP LIGATING LOOP
    Manufacturer
    GENZYME BIOSURGERY
    Date Cleared
    2002-08-20

    (27 days)

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

    GENZYME BIOSURGERY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Saph-Loop™ Ligating Loop is intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Device Description
    Saph-LOOP is the addition of a means for deployment of a length of Tevdek™ suture with a pre-tied knot for ligation of conduit in minimally invasive and general procedures, particularly conduit harvesting procedures. The deployment device consists of a long tube carier with an offset tip at the distal end, a handle and a pull ring at the proximal end.
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    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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