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510(k) Data Aggregation
K Number
K031554Device 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
868.5830Why 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
K030212Device Name
MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE
Manufacturer
GENZYME BIOSURGERY
Date Cleared
2003-03-27
(65 days)
Product Code
NEW
Regulation Number
878.4840Why 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
K022989Device Name
RADLITE TISSUE RETRACTOR SYSTEM
Manufacturer
GENZYME BIOSURGERY
Date Cleared
2002-11-25
(77 days)
Product Code
FSW
Regulation Number
878.4580Why 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
K022410Device Name
SAPH-LOOP LIGATING LOOP
Manufacturer
GENZYME BIOSURGERY
Date Cleared
2002-08-20
(27 days)
Product Code
GAT
Regulation Number
878.5000Why 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
K001440Device Name
NEXTSTITCH CARDIOVASCULAR VALVE SUTURE
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
2000-11-13
(189 days)
Product Code
GAT
Regulation Number
878.5000Why 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
K001434Device 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
878.5000Why 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
K992088Device 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
878.4493Why 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
K991416Device Name
ENDOSCOPIC CAMERA
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
1999-07-20
(88 days)
Product Code
GCJ
Regulation Number
876.1500Why 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
K991191Device 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
878.4493Why 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
K990062Device Name
SAPHLIFT
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
1999-03-30
(81 days)
Product Code
MDM, MDW
Regulation Number
878.4800Why 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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