Search Results
Found 2 results
510(k) Data Aggregation
K Number
K090078Device Name
KERASYS BIOENGINEERED LAMELLAR PATCH GRAFT
Manufacturer
IOP, INC.
Date Cleared
2009-05-08
(116 days)
Product Code
NXM
Regulation Number
886.3130Why did this record match?
Product Code :
NXM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The KaraSys Bioengineered Lamellar Patch Graft is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface. KaraSys is labeled for single use.
Device Description
The KeraSys Bioengineered Lamellar Patch Graft is constructed from four layers of laminated porcine small intestinal submucosa (SIS). The dchydrated device is supplied sterile sealed in a double peel pouch system. Unit size is 1x1.5cm
Ask a Question
K Number
K053622Device Name
SURGISIS OCULAR GRAFT
Manufacturer
IOP, INC.
Date Cleared
2006-03-15
(77 days)
Product Code
NXM
Regulation Number
886.3130Why did this record match?
Product Code :
NXM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SURGISIS Ocular Graft is intended for implantation to reinforce and support the reconstruction of the soft tissue of the eyelid.
The SURGISIS Ocular Graft is intended for implantation to reinforce and aid reconstruction of the eyelid and is labeled for single use.
Device Description
The SURGISIS Ocular Graft is derived from porcine small intestinal submucosa (SIS). The material is prepared into sheets of various sizes and thicknesses appropriate for the reconstruction and repair of soft tissues. The device is supplied sterile in a dry lyophilized state sealed in a double peel pouch system
Ask a Question
Page 1 of 1