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Found 4 results
510(k) Data Aggregation
K Number
K203117Device Name
TissueTak device
Manufacturer
Via Surgical Ltd.
Date Cleared
2021-01-07
(83 days)
Product Code
GDW, DAT
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Via Surgical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TissueTak device is intended for fixation of prosthetic or biologic material to soft tissues in various minimally invasive and open surgical procedures such as hernia or rotator cuff repairs.
Device Description
The TissueTak device is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia or rotator cuff repairs. The Via Surgical TissueTak device, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the TissueTak firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh/patch to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
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K Number
K181668Device Name
FasTouch Absorbable Fixation System
Manufacturer
Via Surgical Ltd.
Date Cleared
2019-03-13
(261 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
Via Surgical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FasTouch Absorbable Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
Device Description
The FasTouch Absorbable Fixation System is a disposable, sterile single-use system designed to deliver absorbable fastener into tissue and prosthesis during general surgery procedures such as hernia repair. The Via Surgical FasTouch Absorbable Fixation System, is designed to be inserted through a 5mm or larger laparoscopic port sleeve. The fasteners two ends are designed to be locked together in the tissue by the Fas Touch firing mechanism, thus forming a closed locked loop into the tissue affixing the surgical mesh to the tissue. The fasteners are absorbable and made of PURASORB PLG 8218 dye with D&C violet No. 2.
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K Number
K162252Device Name
FasTouch Fixation System
Manufacturer
VIA SURGICAL LTD.
Date Cleared
2016-11-14
(96 days)
Product Code
GDW
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
VIA SURGICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FasTouch™ Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
Device Description
The FasTouch™ Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate hernia mesh delivery and placement in laparoscopic or open ventral hernia repair. The FasTouch™ Fixation System is disposable, single-use system designed to deliver a permanent fastener into tissue or prosthesis during general surgery procedures such as hernia repair.
The Via Surgical's FasTouch™ Fixation System is designed to be inserted through a laparoscopic port sleeve. The FasTouch™ Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch™ Fixation System is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.
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K Number
K132698Device Name
FASTOUCH FIXATION SYSTEM
Manufacturer
VIA SURGICAL LTD.
Date Cleared
2014-03-14
(197 days)
Product Code
GDW, REG
Regulation Number
878.4750Why did this record match?
Applicant Name (Manufacturer) :
VIA SURGICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FasTouch Fixation System is intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures such as hernia repairs.
Device Description
The FasTouch Fixation System is a manual laparoscopic surgical instrument which is intended to facilitate fixation of prosthetic material to soft tissue in laparoscopic or open surgical procedures such as ventral hernia repair. The FasTouch Fixation System is disposable, single-use system.
The Via Surgical's FasTouch Fixation System is designed to be inserted through a laparoscopic port sleeve but may be used during open surgical procedures as well. The FasTouch Fixation System is packaged in its unloaded state and contains a handle and a cartridge.
The FasTouch Handle is a multi-fire, sterile, single-use handle that is compatible to work with Via Surgical's FasTouch cartridges (25PS cartridge).
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