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510(k) Data Aggregation
K Number
K082828Device Name
SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2008-10-14
(19 days)
Product Code
GAQ, GAO
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
SUTURTEK INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Suturtek 360° Sternal Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needle stick injuries.
Device Description
The SuturTek 360° Sternal Closure Device™ is a an instrument that is used to pass stainless steel needles through sternum for fixation with stainless steel sutures. It is used to hold and close the sternum after a sternotomy.
The device is sterilized before each use. The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the tissue. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are placed in the same manner and then the ends of the suture are tied together in the usual fashion.
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K Number
K063603Device Name
SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2007-02-07
(66 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
SUTURTEK INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuturTek Surgical Steel Suture is intended for use in sternal closure.
Device Description
The SuturTek Surgical Steel Suture is a sterile, single-use, non absorbable, stainless steel monofilament suture. It is designed to remain inside the patient. It may or may not be attached to a stainless steel needle. The needle and any unused portions of suture are disposables.
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K Number
K032468Device Name
SUTURTEK FASTCLOSE STERNUM CLOSURE DEVICE
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2003-09-23
(43 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
SUTURTEK INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FASTCLOSE Sternum Closure Device is intended for use during thoracic surgery to hold and close the sternum after a sternotomy. It is designed to aid in the prevention of suture needlestick injuries.
Device Description
The FASTCLOSE Sternum Closure Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the sternum to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the sternum. Additional interrupted stitches are place in the same manner and then the two ends of each suture are tied together in the usual fashion.
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K Number
K030227Device Name
SUTURTEK FASTCLOSE SUTURING DEVICE
Manufacturer
SUTURTEK INCORPORATED
Date Cleared
2003-03-17
(54 days)
Product Code
GAL
Regulation Number
878.4830Why did this record match?
Applicant Name (Manufacturer) :
SUTURTEK INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SuturTek FASTCLOSE Suturing Device is intended for soft tissue approximation and/or ligation in general surgical procedures.
The use of this device with absorbable sutures is not indicated for use in cardiovascular and neurological procedures.
It is designed to aid in the prevention of suture needle stick injuries.
Device Description
The FASTCLOSE Device has four major components: 1) a reusable instrument, 2) a single-use, disposable cartridge, 3) a single-use, disposable needle, and 4) sutures.
The cartridge containing the needle (with suture attached) is loaded onto the distal end of the device. The needle is engaged by the device's internal drive mechanism and driven through the tissue to be sutured. The suture is thus passed completely through the wound. Once the suture is in place, the device is withdrawn from the incision leaving the suture strand looped through the tissue. The two ends of the suture are then tied together in the usual manner.
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