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510(k) Data Aggregation
K Number
K153632Device Name
Endoform Reconstructive Template
Manufacturer
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Date Cleared
2016-06-16
(181 days)
Product Code
FTL, FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform® Reconstructive Template is intended for use as a surgical mesh to reinforce and/ or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Device Description
Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.
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K Number
K153633Device Name
Endoform Reconstructive Template
Manufacturer
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
Date Cleared
2016-03-15
(88 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Aroa Biosurgery Limited (Formerly Mesynthes Limited)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endoform Reconstructive Template is intended for usc as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.
Device Description
The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.
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