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510(k) Data Aggregation
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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K Number
K982712Device 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
868.5830Why 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
K980016Device Name
MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
1998-08-07
(217 days)
Product Code
MOP
Regulation Number
870.3935Why 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
K981322Device Name
CUTALON NYLON POLYAMIDE SURGICAL SUTURE
Manufacturer
GENZYME SURGICAL PRODUCT (GENZYME BIOSURGERY)
Date Cleared
1998-07-07
(88 days)
Product Code
GAR
Regulation Number
878.5020Why 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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